5-PLASMA Bivalirudin Control 5D-44905Recalls & reported problems
5-Diagnostics Ltd · Human plasma-based control material intended for quality control of bivalirudin measurements using anti-IIa clotting and chromogenic assay methods. · 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
- Jul 1, 2026Class IIOpen, Classified
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Z-2896-2026 · Root cause: Process control · Recall details · FDA record ↗
Other Plasma, Coagulation Control devices
- STA® - System Control N + P 00678Diagnostica Stago · PLASMA, COAGULATION CONTROL1 recall0 reports
- directCHECK ACT-LR Whole Blood Control, Level 2 000DCGLR-2Accriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 recall0 reports
- BIOPHEN UFH Control Plasma 223101Hyphen Biomed · Plasma, Coagulation Control1 recall0 reports
- directCHECK Whole Blood Controls DCJLR-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control5 reports
- directCHECK Whole Blood Controls DCJLR-NAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control2 reports
- Control Plasma N 10446235Siemens Healthcare Diagnostics Products GmbH · PLASMA, COAGULATION CONTROL1 report
- directCHECK Whole Blood Controls DCJACT-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 report
- directCHECK Whole Blood Controls DCJCPT-AAccriva Diagnostics Holdings, Inc. · Plasma, Coagulation 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
- 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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