FDA Device Recall Z-0021-2013: Beckman Coulter Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2013.

Recall Res Number

Z-0021-2013

Recalling Firm / Manufacturer

Beckman Coulter Inc.

FEI Number

2050012

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-04-03

Date Posted

2012-10-09

Date Terminated

2013-06-20

Product Code

GKZ

Event Number

63158

Product Quantity

1281 units total (693 units in the US)

Product Description Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).

Reason for Recall Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.

Action Details Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated April 3, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an enclosed Response Form. Customers were notified that Beckman Coulter is in the process of developing and testing a design change that will prevent the mix chamber waste port from plugging. Customers with questions were instructed to contact Beckman Coulter Customer service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter representative.

Distribution Pattern Worldwide Distribution-USA (nationwide) and the counties of Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Code Information / Serial Numbers all serial numbers

Related Establishments / Registrations

CYTEK BIOSCIENCES, INC. Registration: 1000292377 View Registration
BECKMAN COULTER, INC. Registration: 1017835 View Registration
SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
BECKMAN COULTER, INC. Registration: 1061932 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
JAS Diagnostics/Drew Scientific Registration: 1064608 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
HAMILTON THORNE, Inc. Registration: 1221433 View Registration
ABBOTT LABORATORIES Registration: 1415939 View Registration
ARKRAY FACTORY USA, INC. Registration: 1832816 View Registration
STRECK LLC Registration: 1950302 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
R & D SYSTEMS, INC. Registration: 2182501 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
ANTIBODIES INCORPORATED Registration: 2914537 View Registration
ABBOTT LABORATORIES Registration: 2919069 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
SYSMEX CORPORATION KAKOGAWA FACTORY Registration: 3002759288 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
Agilent Technologies Singapore (International) Pte Ltd. Registration: 3003423869 View Registration
Flextronics Manufacturing (Singapore) Pte Ltd Registration: 3003589956 View Registration
BIT Analytical Solutions GmbH Registration: 3003601075 View Registration
CELLAVISION AB Registration: 3003630693 View Registration
BOULE MEDICAL AB Registration: 3004008703 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Abbott Laboratories (Singapore) Private Limited Registration: 3006412379 View Registration
Sanmina-SCI Systems Singapore Pte. Ltd. Registration: 3006606827 View Registration
BIT Group France Registration: 3006946274 View Registration
NANOENTEK INC Registration: 3007349751 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
Beckman Coulter Distribution B.V. Registration: 3007750372 View Registration
Immudex, Aps Registration: 3008096179 View Registration
Becton Dickinson Caribe, LTD Registration: 3008352382 View Registration
DIATRON US INC Registration: 3008425728 View Registration
NANOENTEK INC Registration: 3009092698 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
Agilent Technologies Inc. Registration: 3009189893 View Registration
Diatron MI Plc Registration: 3009297077 View Registration
Sysmex America, Inc. Registration: 3009495621 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
KITRON AB Registration: 3009834076 View Registration
Alius Scientific,LLC Registration: 3010324880 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
SYSMEX CORPORATION i-SQUARE Registration: 3010960914 View Registration
Drucker Diagnostics, LLC Registration: 3011765035 View Registration
ATSI Logistics Center ApS Registration: 3013059683 View Registration
ATHELAS Registration: 3013445220 View Registration
PIXCELL MEDICAL Registration: 3013608230 View Registration
BONRAYBIO CO., LTD. Registration: 3014053517 View Registration
BONRAYBIO USA CORPORATION Registration: 3016090200 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
Sysmex America, Inc. - Vernon Hills Registration: 3020704087 View Registration
Becton, Dickinson and Company, BD Biosciences Registration: 3027394506 View Registration
ONECHIPDX BIOTECH (SUZHOU) CO., LTD Registration: 3038625004 View Registration
PIXCELL MEDICAL INC. Registration: 3039523350 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
Immunotech SAS, a Beckman Coulter company Registration: 8023018 View Registration
VTech Communications Ltd Registration: 8040564 View Registration
Agilent Technologies Denmark ApS Registration: 9610099 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration

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Medical Device Recall: Z-0021-2013

Recall Parameters & Description

Related Establishments / Registrations

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