FDA Device recall Z-0265-2018
ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria s…
- FDA Device
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria s… by Biomerieux, citing QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to Fa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0265-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-13 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Reason
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
Identifiers
| code_info | REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110. |
|---|
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-0265-2018%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.