Reported Feb 19, 2020 · Terminated
VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and…
Ortho Clinical Diagnostics Inc.
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 Inc · 1001 US Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+
- and TRIG Product Code1662659
- Lot codes and dates
- Lot # /Exp
- Date
Lot 277 11-Dec-2019Lot 288 31-May-2020Lot 298 12-Nov-2020Lot 219 15-Jul-2021
- UDI10758750009503
- Amount recalled
- 39709 units (12734 US and 26975 OUS)
Where it was sold
- Nationwide
Why it was recalled
Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
This product could cause temporary or reversible health problems — stop using it.
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