AU OSR60135Recalls & reported problems
Beckman Coulter, Inc. · D-Dimer · Class 2
Data updated Oct 13, 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 15099590000332), received between Jun 25, 2020 and Jun 25, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “High Test Results” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Test Results1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2020High Test Results; High Test Results
THE CUSTOMER REPORTED THE GENERATION OF FALSE HIGH D-DIMER PATIENT RESULTS ON THEIR AU5800 CHEMISTRY ANALYZER. THE CUSTOMER REPORTED SIX (6) PATIENTS WERE REFERRED FOR A COMPUTER TOPOGRAPHY (CT) SCAN. THE CT SCANS FOR ALL PATIENTS RETURNED NEGATIVE FOR DEEP-VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). ALTHOUGH NO INFORMATION HAS BEEN RECEIVED REGARDING THE USE OF A CONTRAST MEDIUM IN THE CT SCANS, IT IS HIGHLY LIKELY THAT CONTRAST MEDIUM WAS USED DUE TO THE ASSESSMENT OF DVT AND PE. NO PATIENTS RECEIVED ANY MEDICATIONS OR ANY OTHER PROCEDURES AFTER THE CT SCANS. THE CUSTOMER DID NOT PROVIDE DATA OR PATIENT DEMOGRAPHICS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10196625 ↗
Other Fibrin Split Products devices
- Tina-quant D-Dimer 3001245322Roche Diagnostics GmbH · FIBRIN SPLIT PRODUCTS1 recall2 reports
- Tina-quant D-Dimer 08105618190Roche Diagnostics GmbH · FIBRIN SPLIT PRODUCTS1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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