—#212537

Product

remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

FDA product code: JSI — Culture Media, Selective And Differential
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25

Why it was recalled

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Thermo Fisher Scientific issued an Urgent Medical Device Recall notice to its consignees on 02/13/2025 via US Mail. The notice explained the problem with the product, potential risk to health, and requested the following: "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 R02049 and R02041 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. 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."

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-02-13
Posted by FDA: 2025-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.