Siemens Healthcare Diagnostics, Inc. Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
All lots impacted
Products Sold
All lots impacted
Siemens Healthcare Diagnostics, Inc. is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 due to The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On September 20, 2021, the firm distributed Urgent Medical Device Correction letters to impacted customers. Atellica customers were informed that the resolution of the issue will be implemented in SW v1.25.1. ADVIA customers were informed that the resolution of the issue will be implemented in AP Tool v1.11 and TDef v.1.07. These updates will be available soon. In the interim, customers were provided additional instructions to work around the issue until the update is available. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026