Recall Z-0842-2014— Biomerieux France Chemin De L'Or
Class II · Terminated
Class II FDA medical device recall by Biomerieux France Chemin De L'Or, initiated 2013-11-08, terminated 2017-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.. Reason: bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent..
- Recalling firm
- Biomerieux France Chemin De L'Or
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-08
- Terminated
- 2017-11-30
- Firm location
- Marcy L'Etoile, France
Product description
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
Reason for recall
bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.
Data sourced from openFDA. This site is unofficial and independent of the FDA.