---
title: "FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... — FDA record Z-0022-2025 | Is It on Recall"
description: "Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but th"
url: https://isitonrecall.com/recall/fda-device-z-0022-2025-fastpack-tsh-calibrator-kit-ref-25000024-for-use-in-conjunction-with-the-fastpack-ip-tsh-immunoassay/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack ... — FDA record Z-0022-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- **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.
- **Classification**: Class II
- **Recalling firm**: Qualigen Inc
- **Quantity**: 60
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0022-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0022-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
- [Alabama](https://isitonrecall.com/state/alabama/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Montana](https://isitonrecall.com/state/montana/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Vermont](https://isitonrecall.com/state/vermont/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Oct 16, 2024
- **Recall initiation date**: Aug 26, 2024
- **Center classification date**: Oct 8, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0022-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Qualigen Inc records](https://isitonrecall.com/brand/qualigen-inc/)