FDA Device recall Z-0842-2014
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as… by Biomerieux France Chemin De L Or, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0842-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux France Chemin De L Or |
| Distribution | US |
Product
API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
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.
Identifiers
| code_info | Lot numbers: 1002210010, 1002210011, 1002287930, 1002287931, 1002350760, 1002390940, 1002390941, 1002518070, 1002518071…Lot numbers: 1002210010, 1002210011, 1002287930, 1002287931, 1002350760, 1002390940, 1002390941, 1002518070, 1002518071, 1002518072, 1001915090, 1001915091, 1001915092, 1001932340, 1001998120 and 1002129350. |
|---|
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-0842-2014%22
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