PakAuto®Recalls & reported problems
Immucor Gti Diagnostics, Inc. · PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888234500247), received between Oct 24, 2018 and Oct 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
(B)(6) 2018. THE CUSTOMER RETURNED KIT FROM LOT 3006837 (PA) WAS TESTED IN PARALLEL WITH AN IMMUCOR-WKS RETENTION KIT FROM LOT 3006837 (PA) ON (B)(6) 2018. THE CUSTOMER RETURNED KIT AND THE RETENTION KIT FROM LOT 3006837 (PA) GAVE NEGATIVE CONTROL OD AVERAGE VALUES IN THE IIB/IIIA ROWS THAT DID NOT MEET IFU VALIDITY CRITERIA. THE NEGATIVE SERUM CONTROL IS RUN IN DUPLICATE WITH EACH TEST RUN. THE NEGATIVE SERUM CONTROL SHOULD GIVE AN AVERAGE OD VALUE OF < OR EQUAL TO 0.160 OD IN THE IIB/IIIA ROWS. THE CUSTOMER COMPLAINT ((B)(4)) WAS REPRODUCED. THE CUSTOMER WAS PERFORMING VALIDATION AND STUDY TESTING USING THE KIT. CORRECTIVE ACTION IS BEING TAKEN THROUGH FA-WKS-18-008, TO NOTIFY CUSTOMERS OF THE AFFECTED PAKAUTO LOT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8002478 ↗
Other Test,Platelet Antibody devices
- PakPlus®Immucor Gti Diagnostics, Inc. · Test,Platelet Antibody1 report
- ThromboType®Immucor Gti Diagnostics, Inc. · Test,Platelet Antibody1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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