FDA recall Z-0469-2019

Product

AIA-900 Analyzer, Product code 022930, 022930R

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.

Distribution

Distributed nationwide. Foreign distribution to Canada and Latin America.

Key facts

Status

Terminated

Initiation date

2018-10-05

Report date

2018-11-21

Termination date

2020-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0469-2019