5-PLASMA Bivalirudin Calibrator 5D-46905Recalls & reported problems
5-Diagnostics Ltd · Human plasma-based calibrator material intended for calibration of bivalirudin measurements using anti-IIa clotting and chromogenic assay methods. The product consists of multiple calibration levels and is intended for in vitro diagnostic use by trained laboratory professionals. · 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-2895-2026 · Root cause: Process control · Recall details · FDA record ↗
Other Calibrator, Multi-Analyte Mixture devices
- CAL 3 CAL2351Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture6 recalls0 reports
- VITROS 6844508Ortho-Clinical Diagnostics, Inc. · Calibrator, multi-analyte mixture2 recalls7 reports
- SP CAL (LIQ) IT2691Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture2 recalls0 reports
- VITROS 1662659Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall17 reports
- RAPIDPoint® 500 Measurement Cartridge 10491449Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall3 reports
- ADVIA® Chemistry Calibrator 10312279Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall3 reports
- ADVIA® Chemistry CardioPhase™ hsCRP Calibrators 10335897Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall0 reports
- ADVIA® Chemistry ToxAmmonia Cal 10309217Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page