FDA Device recall Z-1476-2014
FB Reagent (REF 70562)
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of FB Reagent (REF 70562) by Biomerieux, citing 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 Ra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1476-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-06 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are 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
Identifiers
| code_info | Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, E…Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, Exp. Date 8/15/2014, 1002792840, Exp. Date 8/15/2014, 1002834130, Exp. Date 8/22/2014, 1002877370, Exp. Date 8/22/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2014%22
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