Recall Z-0022-2025
Qualigen Inc · initiated August 26, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Codes / lots: UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 8/26/24, correction notices were emailed to customers who were asked to do the following: 1) Dispose of affected TSH calibration cards. 2) Use TSH Calibration Card Lot Number 2405017-1R sent with correction notices. 3) Run TSH Quality Control samples. 4) Review and retest any affected TSH results that may have been higher than expected. 5) Notify all relevant parties within your organization or any organization that received the affected devices. 6) Complete and return response forms via email to systemsupport@qualigeninc.com If you have any questions regarding this matter, contact System Support Specialists at systemsupport@qualigeninc.com or (877) 709-2169, option 2.
Details
- Recall number
- Z-0022-2025
- Initiated
- August 26, 2024
- Posted by FDA
- October 8, 2024
- Product code
- JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
- Quantity
- 60
- 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
- Recalling firm
- Qualigen Inc, Carlsbad, CA