VITROS¿ 3600 Immunodiagnostic System recall: Software Issue
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical…
Why was VITROS¿ 3600 Immunodiagnostic 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: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169
- Product
- VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 682
- Distribution
- US Nationwide Distribution
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)