FDA Device recall Z-2137-2018
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitat…
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitat… by Thermo Fisher, citing product may fail performance testing for S aureus ATCC 43300.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-04 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Thermo Fisher |
| Distribution | US |
Product
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).
Reason
Product may fail performance testing for S aureus ATCC 43300.
Identifiers
| code_info | Lot: 307200 |
|---|
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-2137-2018%22
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