Device 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).
Z-2137-2018
Product summary
- Firm
- Thermo Fisher
- Event
- Event 80068
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 units
- Official record key
device-enforcement:Z-2137-2018
Official wording
Reason: Product may fail performance testing for S aureus ATCC 43300.
Code information: Lot: 307200
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Product may fail performance testing for S aureus ATCC 43300.