FDA Medical Device Recalls (openFDA)
Qualigen Inc: FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- Recall number
- Z-0022-2025
- Recalling firm
- Qualigen Inc
- Product
- FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- Status
- Open, Classified
- Initiated
- 2024-08-26
- Posted
- 2024-10-08
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- 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
- Lot, serial or model codes
- UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
- 510(k) numbers
- ["K052301"]
- PMA numbers
- not on file
- Product code
- JLW
- Firm FEI
- 3003355251
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28