Z-2137-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- December 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67 units
Product Description
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot: 307200