Asserachrom® HPIA 00615Recalls & reported problems
Diagnostica Stago · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 15, 2025Class IIOpen, Classified
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Z-1084-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
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
- 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
- PIFA® Heparin/PF4 Rapid Assay 4036025Akers Biosciences, Inc. · Platelet Factor 4 Radioimmunoassay1 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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