Recall Z-0181-2022 ยท CEK Biuret (Colorimetric), Total Protein
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
| Date | Sep 20, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 Heal |
| Quantity | 246 (US); 689 (OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.