Recall Z-0022-2025 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Qualigen Inc
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
| Date | Oct 8, 2024 (initiated Aug 26, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 systemsupport@qualigeninc.com If you have any questions regarding this matter, contact Syst |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052301 | FASTPACK TSH IMMUNOASSAY Qualigen, Inc., Jan 4, 2006 |