Recall Z-0841-2014— 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: ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.. 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
ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms.
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.