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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CGJ
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