Z-0491-2018 Class II Terminated
FDA device recall Z-0491-2018 was initiated by Tosoh Bioscience Inc on June 11, 2017 and is designated Class II. 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 curr… The recall status is terminated (terminated December 31, 2019). Affected quantity: 565 total devices U.S..
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.