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U.S. Department of Health and Human Services

Class 2 Device Recall Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)

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  Class 2 Device Recall Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) see related information
Date Initiated by Firm September 20, 2021
Create Date October 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-0181-2022
Recall Event ID 88784
Product Classification Biuret (colorimetric), total protein - Product Code CEK
Product Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Code Information All lots impacted
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 246 (US); 689 (OUS)
Distribution Worldwide distribution - US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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