Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0491-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 11, 2017

Date Posted: February 7, 2018

Recall Number: Z-0491-2018

Event ID: 78776

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.

Status: Terminated

Product Quantity: 565 total devices U.S.

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

Voluntary or Mandated:

Voluntary: Firm initiated