FDA Device recall Z-1475-2014
ZYM B Reagent (REF 70493)
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of ZYM B Reagent (REF 70493) 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-1475-2014 |
| 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
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is 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 - 1002706740, Exp. Date 10/14/2014, 1002717860, Exp. Date 10/24/2014, 1002742610, Exp. Date 10/30/2014, 100276070…Codes - 1002706740, Exp. Date 10/14/2014, 1002717860, Exp. Date 10/24/2014, 1002742610, Exp. Date 10/30/2014, 1002760700, Exp. Date 11/4/2014, 1002821420, Exp. Date 11/26/2014, 1002857840, Exp. Date 12/12/2014, 1002860530, Exp. Date 12/12/2014 |
|---|
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-1475-2014%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.