medical Class II Updated 2019-07-31

Abbott Laboratories, Inc recalls Apolipoprotein B is an in vitro diagnostic assay for the qua

Recalled Product

Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.


Hazard / Issue

An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All IFU's
View official government recall

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