Reported Jan 28, 2015 · Terminated
VITROS Software Version 3.1 utilized on the following systems
Ortho-Clinical Diagnostics
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
VITROS Software Version 3.1 utilized on the following systems
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 4600 Chemistry Systems (VITROS 5,1 FS System family member |
| 2 | 5600 Integrated System |
| 3 | VITROS 4600 - in vitro quantitative measurement of a variety of analytes |
| 4 | VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes |
- Lot codes and dates
- System Product Code
1) 68024452) 6802413
- System Product Code
- Amount recalled
- 12 units
Where it was sold
Why it was recalled
Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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