Medical Wire & Equipment (MWE) have announced that the FECAL TRANSWAB® with Liquid Cary Blair Medium Specimen Collection and Transport System has received FDA 510(k) clearance for the preservation and transport of fecal specimens for microbiological testing in clinical laboratories.
Designed to maintain the viability of stool organisms during transport, FECAL TRANSWAB® with Liquid Cary Blair Medium supports both direct rectal swab sampling and collection from a fecal sample. The system fits seamlessly within standard clinical microbiology workflows, with no modification to laboratory processes.
The clearance follows analytical validation using a 50% fecal matrix, a 10-organism test panel, and demonstrated strong performance in the transport of fastidious organisms, including Campylobacter. Clostridium showed 24-hour recovery, with all additional organisms recovered at 48 hours.
The system can be transported and stored at room temperature, offering a practical advantage over solutions requiring continuous refrigeration. Combined with a 24-month shelf life, this provides laboratories and healthcare networks with lower logistical demands and efficient inventory management.
Technical Leadership Commentary
Douglas Shedden, Technical Director at MWE, commented: “Fecal microbiology requires a transport system that supports both robust recovery and practical workflow management. The FECAL TRANSWAB® with Liquid Cary Blair Medium system offers evidence-based transport performance across clinically important organisms while allowing laboratories to reduce dependency on refrigerated logistics. This FDA clearance affirms the quality and reliability we work to deliver across our specimen transport platforms.”
Global Adoption
FECAL TRANSWAB® with Liquid Cary Blair Medium is already widely adopted across Europe, Asia, Australasia and major international health organisations. FDA clearance now enables its availability to clinical laboratories throughout the United States.
