MYCOPREP KIT 75 ML
Received Jan 5, 2026 · Event occurred Oct 10, 2025
Report MW5181691 · MDR key 23958166
Device
Generic name
General Purpose Reagent
Manufacturer
Becton, Dickinson & Co.Catalog number
240862
Lot number
218079
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE IDENTIFIED THE ISSUE THROUGH OUR DAILY LOT TRACKING RECORDS. TWO DAYS AFTER SWITCHING TO LOT# 218079 OF MYCOPREP, ALL SPECIMENS PROCESSED WITH IT FLAGGED POSITIVE WITH BACTERIA, WHICH IS HIGHLY UNUSUAL. NON-RESPIRATORY SPECIMENS IN OUR LABORATORY DO NOT GET PROCESSED WITH MYCOPREP BEFORE BEING PLATED TO MEDIA BECAUSE THEY ARE UNLIKELY TO HAVE BACTERIAL GROWTH. THESE SPECIMENS ARE ALL STILL NEGATIVE TO DATE, THEREFORE WE CONCLUDED THAT IT WAS NOT AN INSTRUMENT, MGIT MEDIA OR PANTA ISSUE. 200 SPECIMENS WERE TREATED WITH THIS LOT NUMBER. WE REPORTED THIS ISSUE TO BD ON (B)(6) 2025. CASE NUMBER (B)(4). PRODUCT WAS IMMEDIATELY SEQUESTERED AND REMOVED FROM USE.