FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP
FDA device recall Z-0022-2025 · posted 2024-10-08 · Open, Classified
Recall details
- Recalling firm
- Qualigen Inc
- 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 taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JLW
- Quantity affected
- 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
- Date initiated
- 2024-08-26
- Date posted
- 2024-10-08
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FASTPACK TSH IMMUNOASSAY (K052301) | Qualigen, Inc. | 2006-01-04 |