PIFA® Heparin/PF4 Rapid Assay 4036025Recalls & reported problems
Akers Biosciences, Inc. · A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA® Heparin/PF4 Rapid Assay. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00708872615123), received between Oct 16, 2020 and Oct 16, 2020 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2020Appropriate Device Problem Term/Code Not Available
PLAINTIFF ALLEGES THAT THE IFU FOR THE PIFA TEST HAS SPECIFIC STORAGE CONDITIONS. PLAINTIFF FURTHER ALLEGES THAT THE CARDINAL HEALTH DEFENDANTS WERE NEGLIGENT IN THE TRANSPORTATION, SHIPPING, STORAGE AND DISTRIBUTION OF THE PIFA TEST INCLUDING IN FAILING TO ENSURE THE PIFA TESTS WERE TRANSPORTED, SHIPPED, STORED, AND DISTRIBUTED IN ACCORDANCE WITH THE IFU; DELIVERING PIFA TESTS THAT HAD NOT BEEN TRANSPORTED, SHIPPED, STORED, AND DISTRIBUTED IN ACCORDANCE WITH THE REQUIREMENTS IN THE IFU; FAILING TO TAKE REASONABLE MEASURES TO PREVENT AFFECTED PIFA TESTS FROM BEING SOLD; FAILING TO REASONABLY ENSURE THAT THE PIFA TESTS REMAINED REFRIGERATED THROUGHOUT THE DISTRIBUTION PROCESS; AND FAILING TO ESTABLISH AND MAINTAIN QUALITY CONTROL TO PREVENT DEFECTIVE SHIPPING AND DISTRIBUTION OF THE PIFA TESTS.
Patient problems: Insufficient Information
MAUDE report 10691976 ↗
Other Platelet Factor 4 Radioimmunoassay devices
- HemosIL AcuStar HIT-IgG (PF4-H) 0009800127Instrumentation Laboratory Company · PLATELET FACTOR 4 RADIOIMMUNOASSAY1 recall4 reports
- ZYMUTEST HIA MonoStrip IgGAM RK041DHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
- ZYMUTEST HIA IgGAM RK040DHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
- Asserachrom® HPIA 00615Diagnostica Stago · PLATELET FACTOR 4 RADIOIMMUNOASSAY1 recall0 reports
- ZYMUTEST HIA IgG RK040AHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
- HemosIL HIT-Ab(PF4-H) 00020014600Instrumentation Laboratory Company · PLATELET FACTOR 4 RADIOIMMUNOASSAY1 death5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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