Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect
Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.
What this means for you
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Tosoh Bioscience Inc is recalling seven units of the AIA-2000 Analyzer, specifically models AIA-2000LA and AIA-2000ST. The affected units are identified by serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, and 80039511. These devices were distributed nationwide in Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.
The recall is due to a potential defect in the liquid suction pump, which may fail to remove sufficient wash solution during the washing step. This incomplete washing can result in falsely elevated test results for sandwich assays and falsely decreased results for competitive binding assays. The issue is detectable through calibration data and quality control trending, such as zero-calibration rates exceeding the acceptance range or failed calibration attempts.
There have been no user or patient injuries reported related to this issue. However, the defect may cause delays in testing and reporting patient results. Users should review their calibration data and QC trending to identify if the issue is present.
The recalled product
- Product
- AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 7
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 (7)
- Serial Nos. 10038409
- 10038509
- 10048009R
- 10058011
- 10069507
- 80018112
- 80039511
Distribution
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