FDA Device Recall Z-0022-2025: Qualigen Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2025.

Recall Res Number

Z-0022-2025

Recalling Firm / Manufacturer

Qualigen Inc

FEI Number

3003355251

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-08-26

Date Posted

2024-10-08

Date Terminated

N/A

Product Code

JLW

Event Number

95326

Product Quantity

Product Description FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

Reason for Recall Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.

Action Details On 8/26/24, correction notices were emailed to customers who were asked to do the following: 1) Dispose of affected TSH calibration cards. 2) Use TSH Calibration Card Lot Number 2405017-1R sent with correction notices. 3) Run TSH Quality Control samples. 4) Review and retest any affected TSH results that may have been higher than expected. 5) Notify all relevant parties within your organization or any organization that received the affected devices. 6) Complete and return response forms via email to systemsupport@qualigeninc.com If you have any questions regarding this matter, contact System Support Specialists at systemsupport@qualigeninc.com or (877) 709-2169, option 2.

Distribution Pattern US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV. OUS: Germany, Switzerland

Code Information / Serial Numbers UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Sterigenics U.S., LLC Registration: 1061124 View Registration
MERCEDES MEDICAL LLC Registration: 1063851 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
TESSY PLASTICS CORP. Registration: 1317202 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
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
JANT PHARMACAL CORP. Registration: 2030633 View Registration
QUALIGEN, INC. Registration: 2032087 View Registration
CTK BIOTECH, INC. Registration: 2032682 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
DRG International, Inc. Registration: 2245285 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
DIAMOND DIAGNOSTICS Inc Registration: 3003030793 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
BTNX Inc. Registration: 3003917514 View Registration
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
DiaSorin Deutschland GmbH Registration: 3004434309 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
ACRO BIOTECH Inc. Registration: 3005360469 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
IDS CO, LTD Registration: 3005655287 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Beckman Coulter Biomedical GmbH Registration: 3006677029 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
NANOENTEK INC Registration: 3007349751 View Registration
CLIAWAIVED,INC. Registration: 3008583799 View Registration
NANOENTEK INC Registration: 3009092698 View Registration
BODITECH MED INC. Registration: 3009491259 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Sysmex America, Inc. Registration: 3009711478 View Registration
Alius Scientific,LLC Registration: 3010324880 View Registration
SYSMEX CORPORATION Registration: 3010421384 View Registration
INPECO SA Registration: 3010825766 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3012073813 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
Kikuyo Factory Registration: 3015969360 View Registration
Roche Diagnostics (Suzhou) Ltd. Registration: 3020917535 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3027519599 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Hangzhou AllTest Biotech Co.,Ltd Registration: 3043127647 View Registration
ASTORIA-PACIFIC, INC. Registration: 3050015 View Registration
BIOMERIEUX SA Registration: 8020790 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
TOSOH CORP. Registration: 8031673 View Registration
WALLAC OY Registration: 8043909 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
SYSMEX CORPORATION TECHNO PARK Registration: 9613959 View Registration
HITACHI HIGH-TECH CORP., NAKA DIVISION Registration: 9614673 View Registration
BIOMERIEUX ITALIA-INDUSTRIAL DIV. Registration: 9615037 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 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-0022-2025

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer