Reported Nov 28, 2018 · Terminated
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three…
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-2000 AnalyzerModel Nos. AIA-2000LA
- AIA-2000ST - Product UsageThe AIA-2000 is capable of
- performing three methods of immunoassayan immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series
- Lot codes and dates
Serial Nos. 100384091003850910048009R10058011100695078001811280039511
- Amount recalled
- 7
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
There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.
This product could cause temporary or reversible health problems — stop using it.
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