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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
Related recalls
Same manufacturer · The Binding Site Group, Ltd.
See all →- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighFreelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy
FDA (Devices) · 2021-12-01
- HighFREELITE Kappa Free Kit quality control bias recall
FDA (Devices) · 2021-07-14
- ModerateBinding Site recalls Optilite Freelite Mx Kappa Free Kits for quality control bias
FDA (Devices) · 2021-02-10
- HighBinding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
FDA (Devices) · 2020-06-03
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighBinding Site Optilite Analyser Recalled for Lid Injury Risk
FDA (Devices) · 2017-01-25
- ModerateBinding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues
FDA (Devices) · 2020-02-26
- ModerateBinding Site Recalls Optilite C-Reactive Protein Kits Due to Deterioration
FDA (Devices) · 2019-12-18
- HighBinding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
FDA (Devices) · 2020-06-03
- LowBinding Site IgG4 Kit Recalled for Incorrect Product Insert Information
FDA (Devices) · 2017-02-01
- ModerateOptilite Freelite Lambda Free Kit Recalled for Inaccurate Test Results
FDA (Devices) · 2017-01-25