Test, Time, Prothrombin

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-03-31Open, ClassifiedEmployee error

  Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

  The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

• 2025-03-31Open, ClassifiedEmployee error

  Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

  The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

• 2022-08-26Open, ClassifiedEnvironmental control

  a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10.

  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.

• 2021-11-23Open, ClassifiedUnder Investigation by firm

  HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

  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 quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

• 2021-01-07TerminatedDevice Design

  CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001

  Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

• 2021-01-07TerminatedDevice Design

  CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001

  Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

• 2019-02-01TerminatedNonconforming Material/Component

  CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

  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 website/telephone/facsimile.

• 2018-11-02TerminatedNonconforming Material/Component

  CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;

  Abnormally high INR test results with the affected CoaguChek test strips

• 2018-03-03TerminatedUnder Investigation by firm

  Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

  Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

• 2016-08-19TerminatedOther

  Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System (Professional Use): The Alere INRatio 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio 2 Monitor and INRatio 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.

  Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.