FDA-Device2018-02-07Class II
Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
Tosoh Bioscience Inc
Hazard
This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
Sold states
Worldwide Distribution - U.S. Nationwide - Latin America
Affected count
565 total devices U.S.
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0491-2018Don't want to check this manually?
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