AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of im...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0600-2019.
Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0600-2019.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
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- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0600-2019.
Tosoh Bioscience Inc
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Tosoh Bioscience Inc Recall FAQ
Tosoh Bioscience Inc is the subject of a diagnostic devices safety report: AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of im.... The notice was published on September 28, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 395 units are potentially affected.