FDA (Devices) recall action 88784
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
The agency’s own wording, quoted from the enforcement report.
Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.