Recall Z-2137-2018 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Thermo Fisher
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).
| Date | May 4, 2018 |
| Status | Terminated |
| Reason | Product may fail performance testing for S aureus ATCC 43300. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by letter on 05/04/2018. The letter stated the following: "Please notify any personnel who need to be aware of the potential for failure of performance for this product. Accordingly, in keeping with our Quality Policy, we request that you inspect your stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. You should review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further actio |
| Quantity | 67 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850291 | MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS Remel Co., May 10, 1985 |