MalfunctionCKD
REFLOTRON GPT
Received Jul 15, 2004
Report 1823260-2004-00575 · MDR key 592428
Device
Generic name
Clinical Chemistry Reagent
Manufacturer
Roche DiagnosticsModel number
NACatalog number
10745138203
Lot number
23717132
Product problems
- Component Missing
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
MANUFACTURING ERROR OCCURRED DURING THE PRODUCTION OF THE SUSPECT TEST STRIPS. AN ALPHA-KETOGLUTARATE COATING IS EITHER PARTIALLY OR ENTIRELY MISSING ON THE TRANSPARENCY FOIL WHICH LEADS TO FALSELY LOW GPT RESULTS FOR PATIENT CONTROLS.
Remedial action
- Recall