Device Recall PREVI Isola System

Serial numbers AS180-00001 to AS180-00376.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.

PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. || Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.