Reported Feb 27, 2019 · Terminated
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic…
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 Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
- Lot codes and dates
- Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
- Amount recalled
- 4030
Where it was sold
- Nationwide
Why it was recalled
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
This product could cause temporary or reversible health problems — stop using it.
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