FDAClass IIJuly 4, 2018

Vidas FSH recall

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…

Why was Vidas FSH recalled?

Invalid calibration with low calibrator S1 while using the product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #1005888210 was distributed in the U.S.

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…
Recalling firm
BioMerieux SA
Quantity
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.
Recall date
July 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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