Reported Nov 21, 2018 · Terminated
AIA-900 Analyzer, Product code 022930, 022930R
Tosoh Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
AIA-900 AnalyzerProduct code 022930022930R
- Lot codes and dates
- All units are affected
- Amount recalled
- 393
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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