Z-1561-2021 Class II Terminated
FDA device recall Z-1561-2021 was initiated by Remel Inc on April 22, 2021 and is designated Class II. Reason for recall: The media allows growth of E. faecalis ATCC 29212 with blackening of the media. The recall status is terminated (terminated August 8, 2023). Affected quantity: 91/10-test units.
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- April 22, 2021
- Termination Date
- August 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91/10-test units
Product Description
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.
Reason for Recall
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Distribution Pattern
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.
Code Information
Lot #248035, Exp. 2021-04-27