FastPack TSH Calibrator (Qualigen) – Barcode Mismatch (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Brand
Qualigen Inc
Lot Codes / Batch Numbers
UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
Products Sold
UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
Qualigen Inc is recalling FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoas due to Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibrati. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, GA, IA, KS, MA, MN, MS, MT, NE, NV, NY, NC, OH, OK, PA, SC, SD, TX, UT, VT, WA, WV, WI, WY
Page updated: Jan 10, 2026