Recall Z-1561-2021 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Remel Inc
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
| Date | Apr 22, 2021 |
| Status | Terminated |
| Reason | The media allows growth of E. faecalis ATCC 29212 with blackening of the media. |
| Root cause | Mixed-up of materials/components |
| Action | The recalling firm issued customer letters dated 4/22/2021 via first class mail to its direct accounts. |
| Quantity | 91/10-test units |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN Remel, L.P., Aug 28, 1997 |