FDA Device recall Z-2126-2017
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimi…
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimi… by Biomerieux, citing potential performance issue on strain categorization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2126-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-01 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
Reason
Potential performance issue on strain categorization.
Identifiers
| code_info | Ref 412302 1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 50705…Ref 412302 1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058 1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2126-2017%22
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