IMMUNO-PREP REAGENT SYSTEM
Received Feb 14, 2012 · Event occurred Jan 18, 2012
Report 1061932-2012-00505 · MDR key 2449367
Device
Generic name
Products, Red-cell Lysing Products
Manufacturer
Beckman Coulter, Inc.Model number
IMMUNO-PREP REAGENTCatalog number
7546999
Lot number
1099062K
Product problems
- Leak/Splash
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).
Description of Event or Problem
A BECKMAN COULTER, INC. (BEC) EMPLOYEE REPORTED THAT BOTTLE A OF THE IMMUNO-PREP REAGENT SYSTEM REAGENT (300 TEST KIT), LOT #1099062K, LEAKED. THE BEC EMPLOYEE REPORTED THAT THERE WAS NEITHER SLACK OF CAP NOR BREAKAGE OF BOTTLE, AND THAT THE PACKAGE WAS INTACT. NO SERVICE REQUEST WAS MADE SINCE THIS WAS AN INTERNAL COMPLAINT FROM A BEC EMPLOYEE. THE ROOT CAUSE OF THE LEAK IS UNKNOWN. THERE WAS NO REPORT OF DEATH OR INJURY AND NO ONE REQUIRED MEDICAL ATTENTION. THERE WAS NO REPORT OF EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.