MalfunctionGTQ
SYNCHRON® ANTISTREPTOLYSIN-O (ASO) REAGENT
Received Jul 30, 2011 · Event occurred Jun 30, 2011
Report 2050012-2011-03918 · MDR key 2184749
Device
Generic name
Streptococcus Spp. Exoenzyme Reagent
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
469165
Lot number
M004439
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEIR SYNCHRON ANTISTREPTOLYSIN-O (ASO) REAGENT CARTRIDGE WAS LEAKING FROM THE BOTTOM SEAM. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.
Additional Manufacturer Narrative
SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A REPLACEMENT WILL BE SENT TO THE CUSTOMER. (B)(4).