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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Remel Blood Agar Biplates Recalled for Listeria Contamination

Agency Publication Date: February 20, 2025
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Summary

Remel, Inc. is recalling 1,103 units of its Blood Agar Biplates, including the MacConkey Agar and EMB Agar variants used for medical diagnostic testing. The recall was issued because the plates may be contaminated with Listeria monocytogenes, which typically appears as visible growth on the blood side of the plate immediately upon opening the packaging. While no injuries or illnesses have been reported, contaminated laboratory media can lead to inaccurate results or potential laboratory exposure. Laboratory personnel should stop using the plates and contact the manufacturer or their distributor to arrange for a return or replacement.

Risk

The presence of Listeria monocytogenes on diagnostic plates can cause inaccurate laboratory results or pose an infection risk to personnel handling the samples. Listeria is a pathogen that can cause serious and sometimes fatal infections, particularly in young children, elderly people, and those with weakened immune systems.

What You Should Do

  1. This recall affects remel Blood Agar MacConkey Agar Biplates (REF R02049) and remel Blood Agar EMB Agar Biplates (REF R02041).
  2. For the MacConkey Agar variant (REF R02049), check for Lot Number 213926 with an expiration date of 2025-02-24 and UDI/DI 848838003691.
  3. For the EMB Agar variant (REF R02041), check for Lot Number 213971 with an expiration date of 2025-02-25 and UDI/DI 848838003684.
  4. Stop using the recalled laboratory products immediately and quarantine any remaining stock to prevent further use.
  5. Contact Remel, Inc. or your medical product distributor to arrange for the return, replacement, or correction of the affected biplates.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: remel BLOOD AGAR MacCONKEY AGAR BIPLATE (QTY 100)
Variants: 100 count
Model / REF:
R02049
Lot Numbers:
213926 (Exp. 2025-02-24)
UDI:
848838003691

Recall #: Z-1200-2025; For invitro diagnostic use.

Product: remel BLOOD AGAR EMB AGAR BIPLATE (QTY 100)
Variants: 100 count
Model / REF:
R02041
Lot Numbers:
213971 (Exp. 2025-02-25)
UDI:
848838003684

Recall #: Z-1201-2025; For invitro diagnostic use.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96312
Status: Active
Manufacturer: Remel, Inc
Sold By: Remel, Inc
Manufactured In: United States
Units Affected: 2 products (787 units; 316 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.