Lower riskMedical device recall · FDA · Published April 22, 2021
Remel Bile Esculin Agar Recall: Risk of False Positive E. faecalis Growth
Remel recalls Bile Esculin Agar with 6mcg/ml Vancomycin (Product #R01186) due to potential false positive E. faecalis growth. Affected units sold for qualitative testing.
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
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Contact the company
📍Recalling firmRemel Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519
✎ GovInfoNow plain-language explainer
Remel is recalling a specific bacterial culture medium used in lab testing because it can grow E. faecalis bacteria and turn black, causing false positive results. This affects labs using the product for detecting antibiotic-resistant bacteria. Read more at govinfonow.com/recall/62746-remel-bile-esculin-agar-recall-risk-of-false-positive-e.
“Remel Bile Esculin Agar Recall: Risk of False Positive E. faecalis Growth.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62746-remel-bile-esculin-agar-recall-risk-of-false-positive-e. Based on FDA recall #Z-1561-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2021%22&limit=1).
The FDA announced on April 22, 2021, that Remel Inc. is recalling Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin due to a hazard where the media allows growth of E. faecalis ATCC 29212 with blackening of the media.
How to tell if you have it
Brand: Remel
Product: Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186
Lot #: 248035
Expiration Date: 2021-04-27
The hazard
The hazard involves the media allowing growth of E. faecalis ATCC 29212 with blackening of the media.
Context
GovInfoNow's records show Remel, Inc has 22 other recalls on record since 2017-11-02. Other recent recalls of similar products include Remel GC Agar Base Recall (2026-06-03), Remel Yeastone Broth Recall (2026-03-24), and Remel Campy CVA Medium 100/PK recall (2026-02-05). Other recent recalls of similar products include Remel Oxoid Agglutinating Sera Recall (2026-03-25), Remel Neisseria meningitidis Gp C 2ml/VL recall (2026-07-17), and Medline Blood Culture Kit Recall (2025-12-24).
How to tell if you have this one
Check for product #R01186, 10 packages, with lot number 248035 and expiration date 2021-04-27. This product is used for qualitative testing of antibiotic-resistant bacteria.
Brand
Remel
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product number (R01186), lot number (248035), and expiration date (2021-04-27) to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Georgia, Illinois, Indiana, Iowa, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1561-2021 (April 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1561-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.