Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue
The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.
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 medical device where a software defect may affect result accuracy, posing a risk of harm through incorrect diagnostic data, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The Binding Site Group, Ltd. is recalling 36 units of the Optilite Clinical Chemistry Analyzer, Model IE700. The recall is due to a software issue that may affect the analyzer's result accuracy.
The affected units are distributed nationwide in the United States, specifically in the states of Alabama, Arkansas, California, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, North Carolina, Nebraska, Ohio, Pennsylvania, Texas, and Virginia. The recall applies to analyzers running with software version 7.0 or 7.01.
Healthcare facilities and users should contact The Binding Site Group, Ltd. for instructions on how to address the software issue. The device is an in vitro diagnostic (IVD) used to measure a variety of analytes.
The recalled product
- Product
- The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on th
- Manufacturer
- The Binding Site Group, Ltd.
- Affected units
- 36
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 (1)
- Analyzers running with software version 7.0 or 7.01
Distribution
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