Recall Z-1475-2014— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2014-03-06, terminated 2017-03-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ZYM B Reagent (REF 70493). The 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: bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent.
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-06
- Terminated
- 2017-03-14
- Firm location
- Marcy L'Etoile, N/A, France
Product description
ZYM B Reagent (REF 70493). The 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
bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
Data sourced from openFDA. This site is unofficial and independent of the FDA.