FDA Medical devices recall ·
FastPack TSH Calibrator Kit recall
- Recall number
- Z-0022-2025
- Date
- (initiated August 26, 2024)
- Company / brand
- Qualigen Inc
2042 Corte Del Nogal, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
States: Alaska Alabama Georgia Iowa Kansas Massachusetts Minnesota Mississippi Montana North Carolina Nebraska Nevada New York Ohio Oklahoma Pennsylvania South Carolina South Dakota Texas Utah Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0022-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.