MERIDIAN CALAS CRYPTOCOCCAL ANTIGEN LATEX
Received Dec 17, 2008 · Event occurred Nov 26, 2008
Report MW5009511 · MDR key 1277356
Device
Generic name
Agglutination System
Lot number
140108.242
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CALAS CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION SYSTEM FROM MERIDIAN BIOSCIENCE, INC. THIS KIT LOT NUMBER IS 140108.242. THE PRONASE FROM THIS KIT (LOT # 1408.169) DID NOT PERFORM WITH REPRODUCIBLE ACCURACY. EACH KIT COMES WITH 2 VIALS OF PRONASE FROM THE SAME LOT. ONE VIAL FROM THIS KIT RESULTED IN 4 POSITIVE SERUM CRYPTOCOCCAL ANTIGENS FROM 2 DIFFERENT PTS. THE SECOND VIAL FROM THE SAME KIT RESULTED IN 4 NEGATIVE SERUM CRYPTOCOCCAL ANTIGENS FROM THE SAME 2 PTS USING SAME SERUM SAMPLES. THE PRONASE THAT RESULTED IN POSITIVE RESULTS WAS CHECKED FOR POSSIBLE CONTAMINATION. IN A CONTROLLED EXPERIMENT, THE PRONASE WAS NOT CONTAMINATED WITH POSITIVE PT SAMPLE OR POSITIVE CONTROL.