Device evidence

device-recall:cfres:127980

BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

Official recall number

Z-2041-2014

Evidence summary

Product code: JSS
Recall status: Terminated
Event initiated: May 21, 2014
Root cause: Labeling mix-ups
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2041-2014