medical Class II Updated 2019-01-02

Tosoh Bioscience Inc recalls AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOST

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: all lots
View official government recall

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