INNOVANCE® D-Dimer Controls 10446006Recalls & reported problems
Siemens Healthcare Diagnostics Products GmbH · INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768023668), received between Oct 6, 2017 and Oct 6, 2017 — classified as 2 malfunctions.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED HIGH, OUT OF RANGE RECOVERY OF D-DIMER CONTROL LEVEL 2 ON THE SYSMEX CA-1500 SYSTEM AFTER CHANGING QUALITY CONTROL (QC) LOTS ON (B)(6) 2017. D-DIMER CONTROL QC LEVEL 1 WAS ALWAYS WITHIN THE TABLE OF ASSIGNED VALUES (TAV) RANGE. A PATIENT SAMPLE WAS RUN AND THE RESULT WAS REPORTED TO THE PHYSICIAN WHILE THE LEVEL 2 QC WAS OUT OF RANGE. THE PHYSICIAN DID NOT QUESTION THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIALLY DISCORDANT D-DIMER RESULT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6922082 ↗MalfunctionOct 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED HIGH, OUT OF RANGE RECOVERY OF D-DIMER CONTROL LEVEL 2 ON THE SYSMEX CA-1500 SYSTEM AFTER CHANGING QUALITY CONTROL (QC) LOTS ON (B)(6) 2017. D-DIMER CONTROL LEVEL 1 WAS ALWAYS WITHIN THE TABLE OF ASSIGNED VALUES (TAV) RANGE. PATIENT SAMPLES WERE RUN AND RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHILE THE LEVEL 2 QC WAS OUT OF RANGE. THE PHYSICIAN(S) DID NOT QUESTION THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIALLY DISCORDANT D-DIMER RESULTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6922077 ↗
Other FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL devices
- STA® - Liatest® D-Di 00515Diagnostica Stago · FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL2 recalls0 reports
- VIDAS® D-Dimer Exclusion II ™ 30455-01Biomerieux SA · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control1 recall2 reports
- INNOVANCE® D-Dimer 10445981Siemens Healthcare Diagnostics Products GmbH · FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL9 reports
- INNOVANCE® D-Dimer 10445982Siemens Healthcare Diagnostics Products GmbH · FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL8 reports
- Alere Triage® 98100Alere San Diego, Inc. · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control4 reports
- Triage 98100Quidel Cardiovascular Inc. · FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL1 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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