Roche CoaguChek XS Plus
Roche · Model CoaguChek XS Plus
• Accurate, precise results in about one minute • The only system to perform onboard quality control and patient tests in a single test chamber • Results unaffected by heparin at therapeutic levels • INR corrected for hematocrit within specified range • Stores 2000 patient and 500 QC test results • Operator and QC lockout to ensure your policies are followed • Calibration via code chip • Stores lot data for up to 60 codes
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
- RECALL
Abnormally high INR test results with the affected CoaguChek test strips
- RECALL
Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
- RECALL
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
- RECALL
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- RECALL
Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
- RECALL
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
- RECALL
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- RECALL
Lack of assurance of sterility.
- RECALL
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
- RECALL
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
- RECALL
Discrepancy between INR and the % Quick displayed on the meter.
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