Reported Nov 28, 2018 · Terminated
Tosoh AIA-900 immunoassay Analyzer
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?
- Tosoh AIA-900 immunoassay Analyzer
- Lot codes and dates
- 10313605 10503612 10634103
- Amount recalled
- 3
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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