Anti-HAV IgM test System recall
Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative…
Why was Anti-HAV IgM test System recalled?
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
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?
APP-file version 04.10-101 on the cobas e 602 module.
- Product
- Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 70,639 units
- Distribution
- US Nationwide Distribution
- Recall date
- February 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)