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Tosoh Bioscience Inc recalls Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated

Recalled February 7, 2018 · FDA recall Z-0491-2018 · Tosoh Bioscience

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. · FDA Class II
Units
565 total devices U.S.
Sold at
Worldwide Distribution - U.S. Nationwide - Latin America

Description

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.

Product
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.
Manufacturer(s)
Tosoh Bioscience Inc

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

Tosoh Bioscience Inc recalls Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated | RecallWatchUSA