Recalls / —

—#214914

Product

Blood/MacConkey Biplate 100/PK, Product Number R02049

FDA product code

JSI — Culture Media, Selective And Differential

Device class

Class 1

Medical specialty

Microbiology

Affected lot / code info

UDI-DI: 848838003684; Lot Numbers: 274194

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Remel, Inc

Address

12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2025-07-11

Posted by FDA

2025-07-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214914. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.