Z-0491-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- June 11, 2017
- Termination Date
- December 31, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 565 total devices U.S.
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - U.S. Nationwide - Latin America
Code Information
All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.