Recall Z-0022-2025— Qualigen Inc
Class II · Ongoing
Class II FDA medical device recall by Qualigen Inc, initiated 2024-08-26. It names one FDA 510(k) clearance: K052301. 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..
- Recalling firm
- Qualigen Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-26
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.