FDA Device recall Z-2095-2017
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial suscepti…
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial suscepti… by Biomerieux, citing false susceptible results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2095-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-25 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
Reason
False susceptible results
Identifiers
| code_info | REF 531640 Lot Number - 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004142070, 1004113370, 10043252…REF 531640 Lot Number - 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004142070, 1004113370, 1004325260, 1004382730, 1004482780, 1004785720, 1004890160, 1005134380, 1005134390, 1005357180, 1005442470 --- REF 531600 - was not distributed in the United States |
|---|
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-2095-2017%22
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