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Coag-sense
COAGUSENSE INC. · Model 100218 · UDI-DI 00861900000336
GJS
Prescription
1
510(k) clearances
26,538
Adverse events (51 deaths)
73
Recalls
32
Facilities
Description
Coag-Sense Test Strip Kit - 50 Ct
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.