VITROS Software Version 3.1 utilized on the following recall
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated…
Why was VITROS Software Version 3.1 utilized on the following recalled?
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
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?
System Product Code: 1) 6802445, 2) 6802413
- Product
- VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 12 units
- Distribution
- Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.
- Recall date
- January 28, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)