Qualigen recalls FastPack TSH Calibrator Kit REF 25000024 due to incorrect barcode linked to wrong information, which may cause TSH test results to be higher than expected. Affected units have specific UDI-DI and lot numbers.
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.
Qualigen is recalling its FastPack TSH Calibrator Kit (REF: 25000024) because the TSH calibrator card has an incorrect barcode that could lead to TSH test results being higher than expected. This might cause inaccurate thyroid hormone measurements if used with the FastPack IP system.
The TSH calibrator card has an incorrect barcode that links to wrong information. This could cause the system to calibrate incorrectly, resulting in TSH test results being higher than expected. Inaccurate results might lead to misdiagnosis of thyroid conditions.
People who own or use the FastPack TSH Calibrator Kit (REF: 25000024) with the FastPack IP TSH Immunoassay system are affected. Those who have used the kit for thyroid hormone testing may be at risk of inaccurate results.
Check for the product name 'FastPack TSH Calibrator Kit' with reference number 25000024. The kit has a UDI-DI code of 00816467020099 and lot number 2405017-1, expiring May 15, 2025.
Verify the reference number 25000024 and UDI-DI code 00816467020099 on the kit.
The TSH calibrator card has an incorrect barcode linked to wrong information, which may cause TSH test results to be higher than expected.
Check the reference number and UDI-DI code on the kit to confirm if it's affected. The recall does not require immediate action but should be addressed if you use the kit for thyroid testing.
No, the recall is for potential inaccurate test results, not a physical hazard. The danger level is low risk.
We’ve drafted a message you can send Qualigen to request your refund or repair — edit it as you like.
Subject: Recall Z-0022-2025 — Qualigen Qualigen Hello, I own a Qualigen that is covered by recall Z-0022-2025 from Qualigen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
