Dade® Owren's Veronal Buffer 10445724Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · Dilution buffer for coagulation testing · Class 2
Data updated Oct 16, 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 00842768003981), received between Sep 14, 2021 and Sep 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 16, 2026.
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
WHILE OPENING A BOTTLE OF OWREN'S VERONAL BUFFER (OVB), THE CUSTOMER RECEIVED A CUT ON THEIR FINGER AFTER THE BOTTLE SHATTERED IN THEIR HAND. THE CUSTOMER CLEANED THE WOUND AND DID NOT SEEK MEDICAL ATTENTION. THE BOX FROM WHICH THE BROKEN BOTTLE WAS TAKEN HAD WET MARKS ON IT AND LOOKED PHYSICALLY DAMAGED. THE CUSTOMER DISCARDED THE REMAINING BOTTLES OF OVB IN THE BOX. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468897 ↗
Other SYSTEM, FIBRINOGEN DETERMINATION devices
- STA® - Fibrinogen 5 00674Diagnostica Stago · SYSTEM, FIBRINOGEN DETERMINATION1 recall0 reports
- Dade® Thrombin Reagent 10445720Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Dade® Thrombin Reagent 10445721Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 report
- Multifibren® U 10446691Siemens Healthcare Diagnostics Products GmbH · SYSTEM, FIBRINOGEN DETERMINATION1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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