FastPack TSH Calibrator Kit, REF: 25000024, For use in… recallZ-0022-2025 · Qualigen Inc · initiated Aug 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Qualigen Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] If you have any questions regarding this matter, contact System Support Specialists at [email protected] or (877) 709-2169, option 2.
Recall details
- Recall number
- Z-0022-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 26, 2024
- Posted by the FDA
- Oct 8, 2024
- Recalling firm
- Qualigen Inc
- Quantity
- 60
- Product code
- JLW
- FDA submissions
- K052301
- 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
Product description
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Code information (models, lots, serial numbers)
UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Calibrator Kit – TSH TSH CalQualigen Inc. · Calibrator, Secondary1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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