Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.
Showing 621–640 of 1,000 recalls
Roche Molecular Systems, Inc.
Kit labeled with the incorrect expiration date.
Ortho-Clinical Diagnostics
If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only.