medical Class II Updated 2018-11-14

Ortho-Clinical Diagnostics recalls VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/

Recalled Product

VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia

Hazard / Issue

The reagent pack exhibits the potential for an increased frequency of calibration failures.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 2601, 2610, 2620
View official government recall

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