FDA Device recall Z-0843-2014
API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella cath…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella cath… 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-0843-2014 |
| 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 NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
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: 1001896203, 1001957530, 1001957531, 1002112170, 1002112171, 1002112172, 1002279351, 1002340500, 1002112173…Lot numbers: 1001896203, 1001957530, 1001957531, 1002112170, 1002112171, 1002112172, 1002279351, 1002340500, 1002112173, 1002171111, 1002171110, 1002279350, 1002279352, 1002340501, 1002340502, 1002340503, 1002412550, 1002412551, 1002485910, 1002485911, 1002455912. |
|---|
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-0843-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.