MalfunctionMYR
AMPCOR
Received Jun 29, 2000 · Event occurred Jun 20, 2000
Report 286009 · MDR key 286009
Device
Generic name
Rpr Test Kit
Manufacturer
Ampcor Technologies Inc. (atiModel number
*Catalog number
*
Lot number
1138
Product problems
- Low Readings
Patient
*
- Misdiagnosis
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
SINCE USING THE AMPCOR RPR KIT IN APRIL-MAY 2000 A 30% DECREASE (3.5% TO 2.2%) IN RPR POSITIVITY RATE HAS BEEN OBSERVED. THE LAB HAS RECEIVED COMPLAINTS OF TITERS BEING TOO LOW. THE PARALLEL TEST OF AMPCOR ANTIGEN VS. ASI AND BD ANTIGEN FAILED IN ONE OF THREE LABORATORIES. A 20% DROP (9.25% TO 7.4%) IN CONFIRMED POSITIVES (POSITIVE FTA'S/TOTAL SPECIMENS TESTED) HAS ALSO BEEN OBSERVED FOR THAT TIME PERIOD.