CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report
FastPack TSH Calibrator Kit recalled by Qualigen
Qualigen is recalling FastPack TSH Calibrator Kit, distributed in 25 states. The recall was initiated on 26 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0022-2025
- FDA event ID
- 95326
- Recalling firm
- Qualigen, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2024
- FDA classified
- 8 Oct 2024
- Reported
- 16 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Aug 2024 | Recall initiated by company | |
| 8 Oct 2024 | Classified by FDA | +43 days |
| 16 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Where it was distributed
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
AlaskaAlabamaGeorgiaIowaKansasMassachusettsMinnesotaMississippiMontanaNorth CarolinaNebraskaNevadaNew YorkOhioOklahomaPennsylvaniaSouth CarolinaSouth DakotaTexasUtah
Questions about this recall
Is FastPack TSH Calibrator Kit recalled?
Yes. Qualigen recalled FastPack TSH Calibrator Kit on 26 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0022-2025.
Why was it 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.
Which lots are affected?
UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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