FDA Adverse Event Injury Summary report: N

REMEL CHOCOLATE AGAR MEDIA

MDR report key: 23390253 · Received October 27, 2025

Report

Report Number
MW5177973
Event Type
Injury
Date Received
October 27, 2025
Date of Event
August 15, 2025
Report Date
October 21, 2025
Manufacturer
REMEL, INC./THERMO FISHER SCIENTIFIC
Product Code
KZI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THERMO FISHER REMEL CHOCOLATE AGAR PART NUMBER R01302 IS NO LONGER GROWING FRANCISELLA TULARENSIS (BACTERIAL CULTURE). EVERY LOT WE HAVE RECEIVED SINCE (B)(6) WILL NOT GROW THE ORGANISM ANYMORE (WE HAVE TRIED MULTIPLE STRAINS OF F. TULARENSIS ON 5 DIFFERENT LOTS OF REMEL CHOCOLATE AGAR SO FAR AND ALL WERE NO GROWTH, WHEREAS BD CHOCOLATE AGAR GREW THE ISOLATES CONCURRENTLY). THIS HAS NEVER BEEN A PROBLEM BEFORE. IT WAS REPORTED TO THE MANUFACTURER AND THEY SAID THEIR MEDIA IS FINE AND THEY HAVE RECEIVED NO OTHER REPORTS. MOST LABORATORIES WILL NOT REALIZE THE ISSUE, AS THEY DO NOT TYPICALLY CULTURE F. TULARENSIS LIKE WE DO. THIS IS A BIG PROBLEM FOR CLINICAL LABORATORIES, AS CHOCOLATE AGAR IS THE ONLY MEDIA USED IN TYPICAL HUMAN SPECIMEN CULTURES (PARTICULARLY FOR BLOOD AND STERILE BODY FLUID CULTURES) THAT IS SUPPOSED TO GROW F. TULARENSIS. PATIENTS WILL BE MISDIAGNOSED, OR AT THE VERY LEAST EXTREMELY DELAYED DIAGNOSIS WILL OCCUR, AS THE LABS WILL NOT KNOW THIS AGENT IS PRESENT. TULAREMIA IS OFTEN A DEADLY DISEASE WITHOUT PROMPT TREATMENT. THIS IS ALSO A BIG SAFETY CONCERN FOR LABORATORY ACQUIRED INFECTIONS, AS POSITIVE BLOOD CULTURES AND BROTH CULTURES MAY BE PRESENT, BUT THE LAB WILL NOT BE ABLE TO ISOLATE COLONIES FOR IDENTIFICATION AND WILL BE EXPOSED WITHOUT REALIZING WHAT THEY ARE WORKING WITH. THERE HAS BEEN AN INCREASE IN TULAREMIA CASES IN THE PAST DECADE OF OVER 50%. REMEL CHOCOLATE AGAR IS NOT SUPPORTING THE GROWTH OF FRANCISELLA TULARENSIS SINCE (B)(6) 2025. THE LAST LOT WE RECEIVED THAT DID GROW THE ORGANISM WAS LOT 284557, EXPIRED 9/3/2025. EVERY LOT AFTER THAT HAS BEEN NEGATIVE FOR GROWTH OF FRANCISELLA TULARENSIS. DIAGNOSIS FOR USE: RULE OUT TULAREMIA. PATIENT CODE: 4582. DEVICE CODES: 2893, 2910. REFERENCE REPORTS: MW5177970, MW5177971, MW5177972, MW5177974.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2794567 REMEL CHOCOLATE AGAR MEDIA CULTURE MEDIA, ENRICHED KZI REMEL, INC./THERMO FISHER SCIENTIFIC 287112

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Life Threatening