CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report
AIA-900 Analyzer, Product recalled by Tosoh Bioscience
Tosoh Bioscience is recalling AIA-900 Analyzer, distributed nationwide in the US. The recall was initiated on 5 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0469-2019
- FDA event ID
- 81187
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2018
- FDA classified
- 14 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Oct 2018 | Recall initiated by company | |
| 14 Nov 2018 | Classified by FDA | +40 days |
| 21 Nov 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
AIA-900 Analyzer, Product code 022930, 022930R
Where it was distributed
Distributed nationwide. Foreign distribution to Canada and Latin America.
Questions about this recall
Why was it 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.
Which lots are affected?
All units are affected
Where was it sold?
Distributed nationwide. Foreign distribution to Canada and Latin America.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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