FDAClass IIOctober 5, 2022

Vidas CMV Igm recall

VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

Why was Vidas CMV Igm recalled?

Invalid calibrations (out of range high) 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 numbers 1008873260, exp. 01JUN2022.

Product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Recalling firm
bioMerieux, Inc.
Quantity
480 kits
Distribution
Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
Recall date
October 5, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls