CAPTURE-R READY-SCREEN TEST WELLS
Received Dec 7, 2006 · Event occurred Nov 30, 2006
Report 1034569-2006-00205 · MDR key 795826
Device
Generic name
Reagent Red Blood Cells
Manufacturer
Immucor, Inc.Model number
*Catalog number
*
Lot number
K103
Product problems
- Replace
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT ANTIBODIES WERE NOT DETECTED ON TWO PATIENT SAMPLES WITH CAPTURE-R READY-SCREEN ON THE GALILEO. ONE PATIENT HAD A PREVIOUSLY IDENTIFIED ANTI-K AND THE OTHER HAD A PREVIOUSLY IDENTIFIED ANTI-FYA. BOTH ANTIBODIES WERE DETECTED USING A GEL METHOD.
Additional Manufacturer Narrative
CUSTOMER SENT SAMPLES FOR INVESTIGATION TESTING. TESTED RETURNED SAMPLES WITH RETURNED AND RETENTION CAPTURE-R READY-SCREEN, LOT K103 ON GALILEO. THE SAMPLE CONTAINING ANTI-FYA WAS NONREACTIVE WITH BOTH THE RETURNED AND RETENTION LOTS. THE SAMPLE CONTAINING ANTI-K REACTED WITH THE RETENTION LOT 1+ BUT WAS NONREACTIVE WITH THE RETURNED LOT. THE SAMPLES WERE TESTED BY TUBE METHOD WITH PANOSCREEN REAGENT RED BLOOD CELLS USING IMMUADD AS THE POTENTIATOR. THE SAMPLES DEMONSTRATED 1+ REACTIONS WITH CELL III AT THE ANTIGLOBULIN PHASE OF TESTING; THIS IS AN EXPECTED REACTION FOR BOTH ANTI-FYA AND ANTI-K. IT IS POSSIBLE THAT THE ANTI-FYA IS AN IGG SUBCLASS 4. HOWEVER, THERE WAS NOT ENOUGH SAMPLE TO PERFORM FURTHER TESTING. THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN STATES: "EXAMPLES OF PURE IGG4 SUBCLASS ANTIBODIES MAY NOT BE DETECTED BY THE CAPTURE-R READY INDICATOR RED CELL REAGENT. NOTE, HOWEVER THAT THE PURE IGG4 ANTIBODIES ARE VERY UNCOMMON."