Recall Z-0469-2019— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-10-05, terminated 2020-11-10. FDA's recall record names no specific 510(k) clearance for this event. Product: AIA-900 Analyzer, Product code 022930, 022930R. Reason: 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..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-05
- Terminated
- 2020-11-10
- Firm location
- Grove City, OH, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.