Recall Z-0180-2022— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0180-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-20

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2021-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-20
Firm location: Tarrytown, NY, United States

Product description

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.