Elecsys Anti-TPO Assay on cobas e analyzers 411 recall
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Why was Elecsys Anti-TPO Assay on cobas e analyzers 411 recalled?
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
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?
All current and upcoming lots
- Product
- Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 11,870 reagent kits
- Distribution
- US Nationwide
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)