Recalls / —

—#217343

Product

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

FDA product code

JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Device class

Class 2

Medical specialty

Microbiology

510(k) numbers

K790687, K802957

Affected lot / code info

1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

Why it was recalled

Products may contain contamination, which may result in a darker or brown media color.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters. Customers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.

Recalling firm

Firm

Remel, Inc

Address

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

Distribution

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.

Timeline

Recall initiated

2025-11-12

Posted by FDA

2025-11-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #217343. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.