Z-0022-2025Class II

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and...

Name: Z-0022-2025 FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and...
Creator: Qualigen Inc
Published: 2024-08-26
License: https://open.fda.gov/license/

Qualigen Inc / initiated 2024-08-26 / Open, Classified / root cause: manufacturing process

FDA source

Qualigen Inc began a recall of FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer on 2024-08-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0022-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-26
Posted: 2024-10-08
Recalling firm: Qualigen Inc
Product: FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected] If you have any questions regarding this matter, contact System Support Specialists at [email protected] or (877) 709-2169, option 2.
Quantity in commerce: 60
Distribution: 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
Product codes and lots: UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0022-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0022-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-08

Product code JLW

K052301Class IIFastpack Tsh ImmunoassayQualigen, Inc. / cleared 2006-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)