FDA (Devices) recall action 77381
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
The agency’s own wording, quoted from the enforcement report.
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M units because they may produce inaccurate ceruloplasmin results below the reference range.
Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control H due to inaccurate ceruloplasmin test results.
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control lots due to inaccurate ceruloplasmin assignment, which may cause patient results to fall below the reference range.