ROCHE DIAGNOSTICS CORP
COAGUCHEK · General Hospital
510(k) Clearances (9)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Recalls (9)
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
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.
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
Discrepancy between INR and the % Quick displayed on the meter.
MAUDE Adverse Events (10)
FDA Classification (66)
General Hospital
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