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U.S. Department of Health and Human Services

Class 2 Device Recall FastPack TSH Calibrator Kit

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 Class 2 Device Recall FastPack TSH Calibrator Kitsee related information
Date Initiated by FirmAugust 26, 2024
Date PostedOctober 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0022-2025
Recall Event ID 95326
510(K)NumberK052301 
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
ProductFastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Code Information UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
Recalling Firm/
Manufacturer		 Qualigen Inc
2042 Corte Del Nogal
Ste B
Carlsbad CA 92011-1438
For Additional Information ContactErin Hoffman
760-918-9165
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 systemsupport@qualigeninc.com If you have any questions regarding this matter, contact System Support Specialists at systemsupport@qualigeninc.com or (877) 709-2169, option 2.
Quantity in Commerce60
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JLW
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