—#187210

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.

FDA product code: JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K972359
Affected lot / code info: Lot #248035, Exp. 2021-04-27

Why it was recalled

The media allows growth of E. faecalis ATCC 29212 with blackening of the media.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The recalling firm issued customer letters dated 4/22/2021 via first class mail to its direct accounts.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

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.

Timeline

Recall initiated: 2021-04-22
Terminated: 2023-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.