FastPack TSH Calibrator Kit — Class II medical device recall Z-0022-2025
Ongoing recall by Qualigen Inc, reported 2024-10-16, distributed in AK, AL, GA, IA, KS, MA, MN, MS…. Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, th
| Recall number | Z-0022-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualigen Inc, Carlsbad, CA, United States |
| Recall initiated | 2024-08-26 |
| Classified | 2024-10-08 |
| Reported by FDA | 2024-10-16 |
| Distributed | 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 |
| Countries outside the US | CH, DE |
| Quantity | 60 |
| UPC / GTIN / UDI-DI | 00816467020099 |
| Lot numbers | 2405017-1 |
| Model numbers | 25000024 |
| Expiration dates | 2025-05-15 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0022-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.