Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
- Recall Initiated
- September 20, 2021
- Recall Number
- Z-0180-2022
- Quantity
- 1402 (US); 2941 (OUS)
- Firm Location
- Tarrytown, NY
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.
Distribution
Worldwide distribution - US Nationwide distribution.
Lot / Code Info
All lots impacted
Root Cause
Software design
Action Taken
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.