SEPTI-CHEK BROTH

Received Feb 3, 1994

Report MW4000169 · MDR key 11388

Device

Manufacturer

Becton Dickinson Microbiology Systems

Lot number

B46NAX, 53401, 1000LEGLGX

Product problems

Contamination

Patient

Narrative

Description of Event or Problem

BELIEVE THE PRODUCT IS CONTAMINATED WITH MAI BACTERIA. OBTAINED FALSE POSITIVE RESULTS IN PTS; ONLY 2 OUT OF 8 WERE ACTUAL NONCONTAMINANTS. TESTED ALL MATERIALS IN USE AND NO CONTAMINATION WAS FOUND.