VITROS 4600 Chemistry System recall: Software Issue
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in…
Why was VITROS 4600 Chemistry System recalled?
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
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?
Product Code: 6802445 UDI: 10758750012343 Serial Numbers: J46000108-J46001132
- Product
- VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 728
- Distribution
- US Nationwide Distribution
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)