Recall Z-1018-2017 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
The Binding Site Group, Ltd.
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, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentrat
| Date | May 13, 2015 |
| Status | Terminated |
| Reason | Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position. |
| Root cause | Component design/selection |
| Action | Binding Site sent an Urgent Field Safety Notice letter dated May 13, 2015 to their customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the Eback Form that this notice has been received and the actions to be taken have been completed to technical.services@bindingsite.co.uk |
| Quantity | 129 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110035 | INDIKO Thermofisher Scientific OY, Jun 28, 2011 |