Recall Z-0006-2015 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
ELITech Clinical Systems SAS
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver a
| Date | Oct 2, 2014 (initiated Aug 11, 2014) |
| Status | Terminated |
| Reason | Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. |
| Root cause | Process control |
| Action | ELITech sent an Urgent Product Recall Notice letter dated August 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To All Users, ***Effective immediately, please discontinue using this product.*** Actions to be taken: "Laboratories must not use this product and must destroy all remaining inventory of the product. "If you have transferred any of this product to another location, please forward a copy of this bulletin to that location. "All users receive ENVOY 500 AST REAGENT KIT, reference 55255, from distri |
| Quantity | 878 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... Elitechgroup Vital Scientific BV, Mar 24, 2011 |