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 Glucose (H-K) test system,
Check against the official notice below — it lists the full affected range.
The Binding Site Group, Ltd. has recalled the Optilite Analyser (Product Code IE700), a fully automated analyzer used in clinical chemistry testing. The recall affects 129 units worldwide, including distribution across multiple U.S. states (California, Virginia, Georgia, Pennsylvania, New Jersey, Kentucky, New York, Arkansas, New Mexico, North Carolina, Alabama, and Michigan) and several countries (Canada, China, Australia, Israel, Ireland, United Kingdom, Germany, Belgium, Italy, France, Czech Republic, Spain, and Portugal).
The recall was initiated due to a potential risk that the Optilite lid/cover may fall suddenly when not placed in the fully open position, which could cause injury to users. Affected units can be identified by their lot/code numbers listed in the recall notice. The source document does not specify a remedy or recommended corrective action for consumers who possess this equipment.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Reason for recall: Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position. Distribution: Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal. Quantity: 129 units Lot/code info: 864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864000290448 864000290837 864000290449 864000290838 864000290452 864000290844 864000290826 864000290845 864000290827 864000290846 864000290828 864000290847 864000290831 864000290850
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.