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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Recalled November 3, 2021 · FDA recall Z-0180-2022 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
1402 (US); 2941 (OUS)
Sold at
Worldwide distribution - US Nationwide distribution.
Description
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.
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →