medical Class II Updated 2019-07-31

Abbott Laboratories, Inc recalls Transferrin is an in vitro diagnostic assay for the quantita

Recalled Product

Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of transferrin 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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