Binding Site Optilite Analyser Recalled for Lid Injury Risk
The Binding Site Group is recalling 129 Optilite Analyser units because the lid may fall suddenly and cause injury if not fully open.
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 risk-of-harm product (potential injury from falling lid) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The Binding Site Group, Ltd. is recalling 129 units of the Optilite Analyser (Product Code: IE700). The recall was initiated due to a potential risk of the device's lid or cover falling suddenly and causing injury if it is not placed in the fully open position.
The affected devices are distributed worldwide, including in the United States (specifically in CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, MI) and in Canada, China, Australia, Israel, Ireland, the UK, Germany, Belgium, Italy, France, the Czech Republic, Spain, and Portugal. The Optilite Analyser is used in conjunction with the Thermo Scientific Indiko Clinical Chemistry Analyzer for in vitro diagnostic testing, such as measuring glucose concentration in human plasma.
Consumers and healthcare facilities should stop using the affected Optilite Analyser units and contact The Binding Site Group, Ltd. for instructions on how to proceed with the recall.
The recalled product
- Product
- Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko 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 the reagent used. The Indiko…
- Manufacturer
- The Binding Site Group, Ltd.
- Affected units
- 129
Distribution
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