CAPTURE-R READY-SCREEN TEST WELLS (POOLED)
Received Sep 14, 2006 · Event occurred Sep 12, 2006
Report 1034569-2006-00116 · MDR key 760787
Device
Product problems
- False Negative Result
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE PRODUCT INVESTIGATION LAB REPORTED UNEXPECTED NEGATIVE REACTIONS FOR FYB, DURING A COMPLAINT INVESTIGATION FOR CAPTURE-R READY-SCREEN (POOLED) TEST WELLS. NEGATIVE REACTIONS WERE OBSERVED WHEN THE PRODUCT WAS TESTED WITH 2 SOURCES OF ANTI-FYB ANTISERA.
Additional Manufacturer Narrative
THIS INVESTIGATION WAS ASSOCIATED WITH A COMPLAINT ABOUT ANOTHER LOT OF PRODUCT, LOT N091. PRODUCT LOTS N091, N092, N093, N094 AND K092 WERE TESTED AND PERFORMED AS EXPECTED; THE REACTIVITY OF THE FYB ANTIGEN WAS CONFIRMED. THE REACTIVITY OF THE FYB ANTIGEN WAS NOT CONFIRMED ON ALL RETENTION PLATES OF CRRS (POOLED), LOT N095. LOT N095 WAS TESTED WITH ANTI-FYB USING IN-HOUSE SAMPLES POSITIVE FOR THE FYB ANTIBODY. INCONSISTENT WEAK REACTIVITY WAS OBSERVED. ADDITIONAL TESTING REVEALED THAT SOME PLATES NEAR THE END OF THE PRODUCTION PROCESS EXHIBITED A WEAKENING OR LOSS OF FYB REACTIVITY WHEN TESTED WITH A SAMPLE DILUTED TO REPRESENT A WEAK ANTIBODY POSITIVE REACTION. REACTIVITY OF UNDILUTED ANTI-FYB SPECIMENS WAS NOT AFFECTED. THE INVESTIGATION IS ONGOING.
Remedial action
- Recall