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 Analyzer
    • Product code 022930
    • 022930R
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 10, 2020 · Data as of Sep 19, 6:17 PM UTC

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