Recall Z-0193-2022 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Siemens Healthcare Diagnostics, Inc.
Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
| Date | Oct 6, 2021 |
| Status | Open, Classified |
| Reason | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions. |
| Root cause | Software design |
| Action | On October 6, 2021, the firm notified affected customers via an "Urgent Medical Device Correction" letter. Customers were informed of the product issue and provided instructions on actions to be taken by laboratories, which prevent the issue from happening. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. A new version of the Firmware for the Aptio Automation Interface Module to the ADVIA Centaur XP/XPT will correct the issue. Your service provider will contact you to schedule the f |
| Quantity | 1142 |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE Dade Behring, Inc., Jan 18, 2005 |