Recall Z-0217-2016 ยท CGA Glucose Oxidase, Glucose
ELITech Clinical Systems SAS
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT
| Date | Nov 5, 2015 (initiated Sep 22, 2015) |
| Status | Terminated |
| Reason | ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received. |
| Root cause | Under Investigation by firm |
| Action | The firm sent recall letters or Technical Bulletins to US consignees on 9/22/15 via registered mail. Technical Bulletin #1022 (for EON 100 users) Technical Bulletin #2008 (for EON 300 users) Technical Bulletin #5064 (for ENVOY users) Technical Bulletin #3009 (for Selectra users) ELITechGroup is not requesting return of the affected product. The method sheets and package inserts will be updated with the new interference claims. When available, the revised labeling will be provided to the customer for customer's use until the new IFU is included in the product packaging. Consignees are reques |
| Quantity | 13455 systems |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100525 | ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2 Seppim S.A.S., Dec 15, 2010 |