MalfunctionKSS
CAPTURE-R READY INDICATOR CELLS
Received Apr 27, 2007 · Event occurred Apr 5, 2007
Report 1034569-2007-00096 · MDR key 956356
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
SALES REPRESENTATIVE REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY INDICATOR RED CELLS, WHEN TESTING A SAMPLE KNOWN TO CONTAIN ANTI-K DURING A DEMONSTRATION OF MANUAL SOLID PHASE TESTING. REPEAT TESTING PERFORMED WITH NEW LOT OF INDICATOR CELLS, RESULTED IN POSITIVE (4+) REACTIONS WITH K POSITIVE CELLS.
Additional Manufacturer Narrative
THE PRESENCE OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN, LOT X185 AND CAPTURE-R READY-ID, LOT ID082 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS, LOT 221988. RETENTION PRODUCTS PERFORMED AS EXPECTED.