medical Class II Updated 2021-11-03

Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP),

Recalled Product

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots impacted
View official government recall

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