Xprecia Prime™ Coagulation Analyzer
UNIVERSAL BIOSENSORS PTY LTD · Model A0297 · UDI-DI 09360136000079
Description
The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determination of International Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-06 | Fisher Diagnostics | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. |
| 2025-03-06 | Fisher Diagnostics | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-04-08 | Instrumentation Laboratory | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reage |
| 2021-10-13 | Instrumentation Laboratory | The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If |
| 2020-12-02 | Roche Diagnostics Operations, Inc. | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| 2020-12-02 | Roche Diagnostics Operations, Inc. | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| 2018-12-20 | TERRIFIC CARE LLC | Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via websi |
| 2018-09-13 | Roche Diagnostics Corporation | Abnormally high INR test results with the affected CoaguChek test strips |
| 2018-08-01 | Instrumentation Laboratory Co. | There is a potential for increased imprecision, out of range quality controls and prolonged sample results. |
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