Coag-sense 100250Recalls & reported problems
Coagusense Inc. · Coag-Sense Professional Control Test Strip Kit - 10 Ct · Class 2
All models of Coag-sense (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
- May 25, 2022Class IIOpen, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1583-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Other Test, Time, Prothrombin devices
- COAGUCHEK XS PT TEST 6 STRIP 4625374160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN3 deaths1,681 reports
- CoaguChek XS PT strips 4625315160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN604 reports
- CoaguChek XS Patient Self Testing Care Kit 03666794001Roche Diagnostics GmbH · Test, Time, Prothrombin212 reports
- CoaguChek XS Patient Self Testing Care Kit 4837738001Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN134 reports
- i-STAT 03P89-24Abbott Point Of Care Inc. · TEST, TIME, PROTHROMBIN127 reports
- HemosIL ReadiPlasTin (20 mL) 00020301400Instrumentation Laboratory Company · TEST, TIME, PROTHROMBIN2 recalls2 reports
- STA® - Néoplastine® CI 10 00666Diagnostica Stago · TEST, TIME, PROTHROMBIN1 recall0 reports
- Coag-Sense Test Strip Kit, 50 ct. 100218Coagusense Inc. · Test, Time, Prothrombin1 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