Tosoh Bioscience Inc recalls AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12

Recalled January 2, 2019 · FDA recall Z-0671-2019 · Tosoh Bioscience

Hazard

Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays · FDA Class II

Units

29645 units

Sold at

US Nationwide

Description

Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays

Product

AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.

Manufacturer(s)

Tosoh Bioscience Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →