Home › Device types › GJS
Test, Time, Prothrombin
FDA product code GJS · Class 2 · Hematology
99
Registered devices
26,576
Adverse events
73
Recalls
127
510(k) clearances
Devices with this code
QuikCoag PT-HS — Biomedica Diagnostics IncXprecia Stride™ Coagulation Analyzer — Siemens Healthcare Diagnostics Inc.CoaguChek XS Pro Kit — Roche Diagnostics GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsmicroINR® Expert Kit — ILINE MICROSYSTEMS SLCoaguChek XS Plus Professional Care Kit — Roche Diagnostics GmbHCoaguChek XS Plus Professional Care Kit — Roche Diagnostics GmbHCoag-sense — COAGUSENSE INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONDade® Innovin® — Siemens Healthcare Diagnostics Products GmbHSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONThromborel S — Siemens Healthcare Diagnostics Products GmbHSTA® - Deficient V — DIAGNOSTICA STAGOCoaguChek Vantus System — Roche Diagnostics GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsAssure PT Care Test Strip Kit — COAGUSENSE INC.Xprecia Prime™ Coagulation Analyzer — UNIVERSAL BIOSENSORS PTY LTDmicroINR ® Link Kit — ILINE MICROSYSTEMS SLDade® Innovin® — Siemens Healthcare Diagnostics Products GmbHCoaguChek XS Professional Use Care Kit — Roche Diagnostics GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsThromboplastin-LI Reagent Kit — HELENA LABORATORIES CORPORATIONThromborel® S — Siemens Healthcare Diagnostics Products GmbHAssure PT Care PT/INR Monitoring System — COAGUSENSE INC.
Recent 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 lot |
| 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 prothro |
| 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 prolonge |
| 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 |
| 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 |
| 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 Me |
| 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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