Remel, Inc recalls Blood/MacConkey Biplate 100/PK

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Blood/MacConkey Biplate 100/PK, Product Number R02049

An Urgent: Medical Device Recall notification letter dated 7/11/25 was sent to customers. ACTIONS TO BE TAKEN BY THE CUSTOMER: Our records indicate that you have received above products. Accordingly, in keeping with our Quality Policy, we request that you please notify any personnel who need to be aware of the potential for visible contamination of products listed above and destroy any remaining inventory of lots listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to MBD.vigilance@thermofisher.com in order for your replacement/credit to be processed. Complete and return the response form even if you no longer have the affected product on hand. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com. TYPE OF ACTION BY THE MANUFACTURER: Remel Inc., part of Thermo Fisher Scientific, is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.

• FDA enforcement recordOfficial FDA database entry for Z-2226-2025
• FDA device classification · JSIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2360The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Remel, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.