AIA-900 Analyzer recall
AIA-900 Analyzer, Product code 022930, 022930R
Why was AIA-900 Analyzer 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units are affected
- Product
- AIA-900 Analyzer, Product code 022930, 022930R
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 393
- Distribution
- Distributed nationwide. Foreign distribution to Canada and Latin America.
- Recall date
- November 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)