VITROS 4600 Chemistry System recall: Software Issue
VITROS 4600 Chemistry System, clinical chemistry analyzer
Why was VITROS 4600 Chemistry System recalled?
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
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: 6900440 UDI: 10758750033201 Affected software : Version 3.3.2 or above
- Product
- VITROS 4600 Chemistry System, clinical chemistry analyzer
- Recalling firm
- Ortho Clinical Diagnostics
- Quantity
- 9
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)