Date Initiated by Firm | September 20, 2021 |
Create Date | October 28, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0180-2022 |
Recall Event ID |
88784 |
Product Classification |
Biuret (colorimetric), total protein - Product Code CEK
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Product | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 |
Code Information |
All lots impacted |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | 914-631-8000 |
Manufacturer 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. |
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 | 1402 (US); 2941 (OUS) |
Distribution | Worldwide distribution - US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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