VITROS 5600 Integrated System recall: Software Issue
VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety…
Why was VITROS 5600 Integrated 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?
1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished) UDI 10758750007110 Serial Numbers: 56000427 56000750 56001012 56001535 56001152 56001641 56000327 56000585 56001437 56000786 56000255 56001235 56000792 56001062 56000308 56001184 56000315 56000458 56001570 56000825 56000661 56000261 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56001264 56000646 56000655 56001027 56001128 56000796 56000890 56000928 56001359 56001851 56000533 56001111 56001689
- Product
- VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 2413
- Distribution
- US Nationwide Distribution
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)