Cobas b 221<4>Roche OMNI S4 system recall: Software Issue
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…
Why was Cobas b 221<4>Roche OMNI S4 system recalled?
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
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?
Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321
- Product
- Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 1026 total products
- Distribution
- USA ( nationwide)
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)