Devices

Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900

Model / Serial
All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - U.S. Nationwide - Latin America
Product Description
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
Tosoh Bioscience Inc
1 Event
- Recall of Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900

Manufacturer

Tosoh Bioscience Inc

Manufacturer Address
Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
Manufacturer Parent Company (2017)
Tosoh Corp.
Source
USFDA

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