TPHA Screen 0066826Recalls & reported problems
Immucor, Inc. · TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and EDTA plasma by passive hemagglutination using an automated Blood Bank system. The product configuration is ten (10) vials. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888234001485), received between Jun 7, 2016 and May 25, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- False Negative Result2
- Insufficient Device Problem Information1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2017Insufficient Device Problem Information
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).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6592307 ↗MalfunctionSep 22, 2016False Negative Result
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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5971028 ↗MalfunctionJun 7, 2016False Negative Result
ON (B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE OUTCOMES WHEN VALIDATING AN INSTRUMENT ASSAY FOR TPHA ASSAY, USING TPHA SCREEN TEST CELLS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5702972 ↗
Other Test,Donor,Syphilis,Antigens,Treponemal devices
- Elecsys Syphilis 09015051162Roche Diagnostics GmbH · Test, donor, syphilis, antigens, treponemal2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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