Z-0022-2025 Class II Ongoing
FDA device recall Z-0022-2025 was initiated by Qualigen Inc on August 26, 2024 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 60.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- August 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60
Product Description
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.
Distribution Pattern
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
Code Information
UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15