Device 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.
Z-0491-2018
Product summary
- Event
- Event 78776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 565 total devices U.S.
- Official record key
device-enforcement:Z-0491-2018
Official wording
Reason: 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.
Code information: All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
Distribution pattern: Worldwide Distribution - U.S. Nationwide - Latin America
Derived failure modes
-
Unknown
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.