CMV Igm EIA recall
CMV IgM EIA, in vitro diagnostic.
Why was CMV Igm EIA recalled?
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
- Product
- CMV IgM EIA, in vitro diagnostic.
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Quantity
- 180 kits
- Distribution
- U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
- Recall date
- December 7, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)