Reported Aug 14, 2019 · Terminated
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Ortho Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Lot codes and dates
- product code6844508
- UDI10758750032105
- Affected Assay Data Disk (ADD) DRV NoDRV 6032 or above
- Amount recalled
- N/A
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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