TPHA SCREEN TEST CELLS
Received Sep 22, 2016 · Event occurred Jun 22, 2016
Report 1034569-2016-00248 · MDR key 5971028
Device
Generic name
For The Detection Of Antibodies To Treponema Pallidum
Manufacturer
Immucor, Inc.Catalog number
0066826
Lot number
280006
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IMMUCOR TECHNICAL SUPPORT ASSESSED THE TEST WELL IMAGES ON THE TESTING INSTRUMENT USING A REMOTE ELECTRONIC CONNECTION METHOD ON (B)(6) 2016. THE TEST WELLS WERE VISUALLY NEGATIVE. THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(6) 2016, WHICH PERFORMED AS EXPECTED. ADDITIONAL TESTING WAS PERFORMED USING THE RESEARCH USE ONLY SERACARE PANEL, WHICH YIELDED INCONSISTENT RESULTS, WHICH REPRODUCED THE CUSTOMER'S OBSERVATION.
Description of Event or Problem
ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE OUTCOMES WHEN VALIDATING AN INSTRUMENT ASSAY FOR TPHA ASSAY, USING TPHA SCREEN TEST CELLS ON A GALILEO NEO.