Roche CoaguChek XS Prothrombin Time Test Strips Recalled for High INR Results
Roche Diagnostics is recalling CoaguChek XS Prothrombin Time test strips nationwide because they may produce abnormally high INR results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce inaccurate test results (abnormally high INR), which poses a risk of harm to patients through potential mismanagement of anticoagulation therapy, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Corporation is recalling specific lots of CoaguChek XS System Prothrombin Time (PT) test strips. The affected products include the CoaguChek XS PT Test 2X24 Strips, 6 Strips, and 24 Tests, distributed nationwide. The recall involves approximately 1,163,952 boxes of the test strips.
The recall was initiated because the affected test strips may produce abnormally high International Normalized Ratio (INR) test results. This potential for inaccurate readings could impact the monitoring of patients using the device.
Consumers and healthcare providers should stop using the affected test strips and contact Roche Diagnostics for further instructions or a replacement. The specific lot numbers and catalog numbers affected are detailed in the official recall notice.
The recalled product
- Product
- 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;
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 1,163,952
Distribution
Distributed nationwide across the United States.
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