Recall Z-1477-2014— 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: API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most 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
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most 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.