FDA Device Recall Z-0029-2014: OPTI Medical Systems, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-2014.

Recall Res Number

Z-0029-2014

Recalling Firm / Manufacturer

OPTI Medical Systems, Inc

FEI Number

3004102403

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-08-09

Date Posted

2013-10-18

Date Terminated

2013-12-12

Product Code

JJE

Event Number

66105

Product Quantity

361 boxes of 25 cassettes each

Product Description Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

Reason for Recall OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

Action Details The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: technicalsupport@optimedical.com Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.

Distribution Pattern Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.

Code Information / Serial Numbers Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812

Related Establishments / Registrations

HORIBA LTD. Registration: 1000256526 View Registration
BIOTECNICA INSTRUMENTS, Srl Registration: 1000455123 View Registration
AWARENESS TECHNOLOGY, INC. Registration: 1036223 View Registration
SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
NOVA BIOMEDICAL CORPORATION Registration: 1219029 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
MEDICA CORP. Registration: 1220972 View Registration
TESSY PLASTICS CORP. Registration: 1317202 View Registration
CURRIER PLASTICS Registration: 1319436 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319809 View Registration
ABBOTT LABORATORIES Registration: 1415939 View Registration
Nypro Inc. (Chicago) Registration: 1424235 View Registration
STANBIO LABORATORY Registration: 1616487 View Registration
Fujirebio Diagnostics, Inc. Registration: 1643621 View Registration
ELITechGroup Inc Registration: 1717966 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
Trinity Biotech (Primus Corporation dba Trinity Biotech) Registration: 1931251 View Registration
HYCOR BIOMEDICAL Registration: 2016473 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
Alere San Diego, Inc. Registration: 2027969 View Registration
Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
Diazyme Laboratories, Inc. Registration: 2032900 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
DIASORIN INC. Registration: 2182595 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
ABBOTT POINT OF CARE INC. Registration: 2245578 View Registration
ALFA WASSERMANN Registration: 2247288 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. Registration: 2435505 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Classic Industries, Inc. Registration: 2523553 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
HAMILTON CO. Registration: 2915796 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
BIO-RAD Registration: 3002889627 View Registration
Fujirebio Inc. Registration: 3002895169 View Registration
DIAMOND DIAGNOSTICS Inc Registration: 3003030793 View Registration
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG Registration: 3003268355 View Registration
TECAN SCHWEIZ AG Registration: 3003402518 View Registration
NPA de México S. de R.L. de C.V. Registration: 3003542872 View Registration
Tecan Trading AG Registration: 3003559191 View Registration
Flextronics Manufacturing (Singapore) Pte Ltd Registration: 3003589956 View Registration
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
JEOL LTD. Registration: 3003637681 View Registration
DIRUI INDUSTRIAL CO., LTD. Registration: 3003741796 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
BTNX Inc. Registration: 3003917514 View Registration
OPTI MEDICAL SYSTEMS INC. Registration: 3004102403 View Registration
TAIDOC TECHNOLOGY CORPORATION Registration: 3004145393 View Registration
Biolis Medical Corp. Registration: 3004378326 View Registration
DiaSorin Deutschland GmbH Registration: 3004434309 View Registration
FURUNO ELECTRIC CO., LTD. Registration: 3004438098 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
Tosoh Hi-Tec, Inc. Registration: 3004529019 View Registration
PHADIA US INC. Registration: 3004973408 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
LABSYSTEMS DIAGNOSTICS Registration: 3005342322 View Registration
INPECO S.P.A. Registration: 3005509212 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
OTSUKA ELECTRONICS CO., LTD. Registration: 3005622096 View Registration
ABBOTT POINT OF CARE CANADA LIMITED Registration: 3005643513 View Registration
IDS CO, LTD Registration: 3005655287 View Registration
PRECISION SYSTEM SCIENCE COMPANY LIMITED Registration: 3005748564 View Registration
YAMURA ELECTRIC INDUSTRY CO., LTD. Registration: 3005748784 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Beckman Coulter Biomedical GmbH Registration: 3006677029 View Registration
MEDICON HELLAS SA Registration: 3006716639 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
EUROIMMUN US INC. Registration: 3007118747 View Registration
Carclo Technical Plastics - Latrobe Registration: 3007135420 View Registration
GOLD STANDARD DIAGNOSTICS, LLC Registration: 3007208259 View Registration
EUROIMMUN Medizinische Labordiagnostika AG Registration: 3007361513 View Registration
Immunodiagnostic Systems SA Registration: 3007500635 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
VitalScientific Registration: 3007662974 View Registration
Beckman Coulter K. K. Registration: 3008244372 View Registration
ABBOTT IRELAND Registration: 3008344661 View Registration
DIATRON US INC Registration: 3008425728 View Registration
STRATEC Switzerland AG Registration: 3008494306 View Registration
ZHEJIANG ORIENT GENE BIOTECH Registration: 3008517993 View Registration
DiaSorin Italia S.p.A UK Branch Registration: 3008576040 View Registration
Ningbo MedicalSystem Biotechnology Co., Ltd. Registration: 3008853996 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
HEALGEN SCIENTIFIC LLC Registration: 3009238284 View Registration
Diatron MI Plc Registration: 3009297077 View Registration
Randox Teoranta Registration: 3009473156 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
GETEIN BIOTECH, INC. Registration: 3009984016 View Registration
Yantai Addcare Bio-Tech Co., Ltd. Registration: 3010031137 View Registration
Alius Scientific,LLC Registration: 3010324880 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD Registration: 3010610113 View Registration
INPECO SA Registration: 3010825766 View Registration
IXENSOR CO LTD Registration: 3011061417 View Registration
MGS GERMANTOWN A DIVISION OF MGS GROUP NA INC Registration: 3011179004 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
FANDF CO., LTD. MEDICAL DEVICE DEPARTMENT Registration: 3012057020 View Registration
THE BINDING SITE Registration: 3012471076 View Registration
WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD. Registration: 3012526002 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
STS CORPORATION Registration: 3014150341 View Registration
BIOBASE BIODUSTRY(SHANDONG)CO., LTD Registration: 3014325803 View Registration
PHC Corporation Registration: 3014353045 View Registration
RANDOX LABORATORIES LIMITED Registration: 3014607865 View Registration
Fujirebio Inc. Ube Facility Registration: 3014643041 View Registration
TN MICHIGAN, LLC Registration: 3014717638 View Registration
Hitachi High-Tech Corp., Omuta Center Registration: 3014840402 View Registration
Kikuyo Factory Registration: 3015969360 View Registration
Abbott Laboratories de Mexico Registration: 3016244760 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
SHENZHEN YHLO BIOTECH CO., LTD. Registration: 3017019647 View Registration
ZYBIO INC. Registration: 3017098905 View Registration
iXensor USA Inc Registration: 3017548799 View Registration
BEIJING HOTGEN BIOTECH CO., LTD. Registration: 3017894300 View Registration
DONGGUAN BAO KANG DIAN ZI KE JI LIMITED Registration: 3020978007 View Registration
Beckman Coulter Biomedical GmbH Registration: 3021394862 View Registration
Nova Biomedical Corporation Registration: 3023162659 View Registration
Abbott Automation Solutions GmbH Registration: 3023268435 View Registration
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. Registration: 3027977508 View Registration
PHC Corporation Registration: 3029973107 View Registration
SHANGHAI KEHUA LABORATORY SYSTEM CO., LTD. Registration: 3030234142 View Registration
SHENZHEN INCRECARE BIOTECH CO., LTD Registration: 3030493719 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Westfall Technik Chicago Registration: 3034707949 View Registration
Bio-Rad Service France SAS Registration: 3035708936 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
SAFAS Registration: 3042177088 View Registration
SPIRAL SA LABORATORIES Registration: 3042244350 View Registration
CELLLAB INTERNATIONAL LLC Registration: 3042268054 View Registration
LMSI, LLC dba Lighthouse Lab Services Registration: 3044473429 View Registration
Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
IMMUNODIAGNOSTIC SYSTEMS LTD. Registration: 8021924 View Registration
BIO-RAD Registration: 8023060 View Registration
VitalScientific B.V. Registration: 8030478 View Registration
TOSOH CORP. Registration: 8031673 View Registration
STRATEC SE Registration: 8043379 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
PHADIA AB Registration: 9610566 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
THERMO FISHER SCIENTIFIC OY Registration: 9610942 View Registration
Beckman Coulter Mishima K.K. Registration: 9612296 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration
The Binding Site Group Ltd. Registration: 9614373 View Registration
HITACHI HIGH-TECH CORP., NAKA DIVISION Registration: 9614673 View Registration
CANON INC. Registration: 9614698 View Registration
BIOMERIEUX ITALIA-INDUSTRIAL DIV. Registration: 9615037 View Registration
DIESSE DIAGNOSTICA SENESE S.P.A Registration: 9615056 View Registration
BIOMERIEUX SA Registration: 9615754 View Registration
Fujirebio Europe N.V. Registration: 9615837 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration
SENTINEL CH. SPA Registration: 9681753 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0029-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer