inforMED
MalfunctionCEK

SYNCHRON CX TOTAL PROTEIN REAGENT

Received Dec 10, 2010 · Event occurred Nov 1, 2010

Report 2050012-2010-01644 · MDR key 1918975

Device

Generic name

Total Protein Reagent

Model number

NA

Catalog number

442740

Lot number

NA

Product problems

  • Leak/Splash

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEY RECEIVED LEAKING TOTAL PROTEIN (TP) REAGENT CARTRIDGES. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER WAS SENT REPLACEMENT.

Remedial action

  • Replace