FDA Device recall Z-0442-2016
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility o…
- FDA Device
- Class I
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class I recall of Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility o… by Biomerieux, citing due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0442-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-11-19 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Reason
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
Identifiers
| code_info | Ref. 521458, Lot numbers: 1004397280, 1004271100, 1003977350, 1003903650, 1003561810, 1003239850, 1002489700, 1002273480, 1002216620 and 1002120370. |
|---|
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-0442-2016%22
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