remel SUPERPACK CS/ 500 SEG/FLASK — Class II medical device recall Z-2137-2018
Terminated recall by Thermo Fisher, reported 2018-06-20, distributed nationwide. Product may fail performance testing for S aureus ATCC 43300.
| Recall number | Z-2137-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermo Fisher, Lenexa, KS, United States |
| Recall initiated | 2018-05-04 |
| Classified | 2018-06-08 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2018-12-19 |
| Distributed | Nationwide (US) |
| Quantity | 67 units |
| Reason classes | device malfunction |
| Lot numbers | 307200 |
| Model numbers | R01626 |
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 for recall
Product may fail performance testing for S aureus ATCC 43300.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2137-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.