FDA Device recall Z-0022-2025
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer by Qualigen, citing thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0022-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-26 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Qualigen |
| Distribution | AK, AL, GA, IA, KS, MA, MN, MS, MT, NC, NE, NV, NY, OH, OK, PA, SC, SD, TX, UT, VT, WA, WI, WV, WY |
Product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
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.
Identifiers
| code_info | UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2025%22
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