FDA Device recall Z-1478-2014
API Listeria (REF 10300)
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of API Listeria (REF 10300) 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-1478-2014 |
| 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
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs 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
Identifiers
| code_info | Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, E…Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, Exp. Date 7/18/2014, 1002856800, Exp. Date 6/12/2014 |
|---|
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-1478-2014%22
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