FDA Enforcement
Class II
Ongoing
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Recall: Z-0022-2025
·
Reported October 16, 2024
Enforcement
- Recall Number
- Z-0022-2025
- Event ID
- 95326
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Qualigen Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 16, 2024
- Initiation Date
- August 26, 2024
- Classification Date
- October 8, 2024
- Address
- 2042 Corte Del Nogal, Ste B, Carlsbad, CA, 92011-1438, United States
Description
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.
Code Info
UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
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
Quantity
60