Tosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction
Tosoh Bioscience is recalling 393 AIA-900 Analyzers because a pickup arm malfunction can stop the device from testing patient samples, causing delays in results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a malfunction causes a delay in patient testing and reporting results. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, which corresponds to a score of 3.
Plain-English summary
Tosoh Bioscience Inc is recalling 393 units of the AIA-900 Analyzer (product codes 022930 and 022930R). The recall was initiated after the company identified a potential issue with the pickup arm and pickup arm motor. The affected units were distributed nationwide in the United States, as well as to Canada and Latin America.
If the pickup arm or motor malfunctions, the analyzer will cease to function, resulting in an inability to test patient samples. This failure may cause delays in testing and reporting patient results. Tosoh has received 51 complaints related to this issue, but no serious injuries have been reported.
Healthcare facilities and users should stop using the affected AIA-900 Analyzers and contact Tosoh Bioscience for instructions on how to resolve the issue.
The recalled product
- Product
- AIA-900 Analyzer, Product code 022930, 022930R
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 393
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units are affected
Distribution
Distributed nationwide across the United States.
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