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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS FSH

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  Class 2 Device Recall VIDAS FSH see related information
Date Initiated by Firm April 09, 2018
Date Posted June 29, 2018
Recall Status1 Completed
Recall Number Z-2331-2018
Recall Event ID 79620
510(K)Number K921746  
Product Classification Radioimmunoassay, follicle-stimulating hormone - Product Code CGJ
Product VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France.

For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.
Code Information Lot #1005888210 was distributed in the U.S.
Recalling Firm/
Manufacturer
BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information Contact Debra Broyles
314-731-8805
Manufacturer Reason
for Recall
Invalid calibration with low calibrator S1 while using the product.
FDA Determined
Cause 2
Under Investigation by firm
Action The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.
Quantity in Commerce 59 units distributed to the U.S.
Distribution Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = CGJ and Original Applicant = BIOMERIEUX VITEK, INC.
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