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Open, Classified

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

FDA Recall Z-0022-2025 · Posted 2024-10-08

Recalling FirmQualigen Inc
Recall StatusOpen, Classified
Product CodeJLW
Date Initiated2024-08-26
Product Quantity60

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.

Firm 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 [email protected] If you have any questions regarding this matter, contact System Support Specialists at [email protected] or (877) 709-2169, option 2.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052301FASTPACK TSH IMMUNOASSAYQualigen, Inc. · 2006-01-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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