Z-1561-2021Class II

Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package -

Name: Z-1561-2021 Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package -
Creator: Remel Inc
Published: 2021-04-22
License: https://open.fda.gov/license/

Remel Inc / initiated 2021-04-22 / Terminated

FDA source

Remel Inc began a recall of Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for... on 2021-04-22. FDA classified it as Class II and gives the reason as "The media allows growth of E. faecalis ATCC 29212 with blackening of the media". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1561-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-22
Posted: 2021-05-12
Terminated: 2023-08-08
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.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
FDA 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 in commerce: 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.
Product codes and lots: Lot #248035, Exp. 2021-04-27

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1561-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1561-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12

Product code JSO

K972359Class IIRemel Bile Esculin Azide Agar W/6 Mcg/ml VancomycinRemel, L.P. / cleared 1997-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)