FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1561-2021
- Recalling firm
- Remel Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-04-22
- Posted
- not on file
- Terminated
- 2023-08-08
- 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.
- Lot, serial or model codes
- Lot #248035, Exp. 2021-04-27
- 510(k) numbers
- ["K972359"]
- PMA numbers
- not on file
- Product code
- JSO
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28