COULTER® 4C® PLUS CELL CONTROL
Received May 18, 2011 · Event occurred Apr 18, 2011
Report 1061932-2011-00418 · MDR key 2092665
Device
Generic name
Hematology Quality Control Mixture
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
7547114
Lot number
085700
Product problems
- Crack
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE OPERATOR WAS PROVIDED WITH A REPLACEMENT. AT THIS TIME, THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. PER LABELING, THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THEIR COULTER 4C PLUS CELL CONTROL VIAL WAS CRACKED WHEN RECEIVED. THE LEAKAGE WAS CONTAINED WITHIN THE PACKAGING. THE CONTROL VIAL WAS NOT RUN ON THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES WHEN HANDLING THE CONTROL MATERIAL. NO EXPOSURE OCCURRED TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO DEATH, SERIOUS INJURY, OR AFFECT TO USER HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.
Remedial action
- Replace