Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0469-2019)

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:

AIA-900 Analyzer, Product code 022930, 022930R

Product Classification:

Class II

Date Initiated: October 5, 2018

Date Posted: November 21, 2018

Recall Number: Z-0469-2019

Event ID: 81187

Reason for Recall:

Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.

Status: Terminated

Product Quantity: 393

Code Information:

All units are affected

Distribution Pattern:

Distributed nationwide. Foreign distribution to Canada and Latin America.

Voluntary or Mandated:

Voluntary: Firm initiated