VITROS 5600 Integrated System recall: Software Issue
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative…
Why was VITROS 5600 Integrated System recalled?
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
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?
Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
- Product
- VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 1830 Total: USA - 877, Foreign - 953
- Distribution
- Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
- Recall date
- January 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)