MalfunctionDCK
C-REACTIVE PROTEIN (LATEX)
Received Aug 2, 2001 · Event occurred Aug 1, 2001
Report 1823260-2001-00166 · MDR key 347104
Device
Generic name
Reagent Cassette
Manufacturer
Roche DiagnosticsModel number
NACatalog number
0764930
Lot number
156081-01
Product problems
- Design/structure problem
- Nonstandard Device
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
NOTIFIED BY GLOBAL AFFILIATE THAT REAGENT CASSETTES MAY CONTAIN UNDER-FILLED OR NEARLY EMPTY REAGENT BOTTLES. ANALYZER DOES NOT CONTAIN LEVEL DETECTION SYSTEM THEREFORE NO ALARM WOULD WARN CUSTOMERS. PATIENT SAMPLES AND CONTROLS MAY PRODUCE FALSELY LOW OR HIGH RESULTS WITHOUT AN ALARM OR THERE COULD BE UNACCEPTABLE PRECISION WHEN PATIENT OR CONTROL MATERIAL IS REPORTED.
Remedial action
- Recall