FDA-Device2019-01-02Class II
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
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Sold states
US Nationwide
Affected count
29645 units
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0671-2019More Tosoh Bioscience Inc recalls
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