MalfunctionMYR
TPHA SCREEN TEST CELLS
Received May 25, 2017 · Event occurred May 10, 2017
Report 1034569-2017-00094 · MDR key 6592307
Device
Generic name
For The Detection Of Antibodies To Treponema Pallidum
Manufacturer
Immucor, Inc.Catalog number
0066826
Lot number
280006
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE IMMUCOR REVIEW CONCLUDED THAT THE PROBABILITY OF OCCURRENCE OF HARM (POH) IS IMPROBABLE (B)(6). THE SEVERITY OF A TRANSFUSION TRANSMITTED (B)(6) IS CONSIDERED SERIOUS BECAUSE THE RESULTING INJURY (INFECTION) WOULD REQUIRE MEDICAL ATTENTION. THIS MDR IS LINKED TO (B)(6).
Description of Event or Problem
ON (B)(6) 2017, IMMUCOR DEEMED AN MDR REPORTABLE TO FDA, DUE THIRTY (30) DAYS FROM THE DATE OF (B)(6) 2017 FOR TPHA SCREEN TEST CELLS (LOT NUMBER 280006).