| | Class 2 Device Recall Aptio AutomationAptio Automation Interface Module to ADVIA Centaur XP/XPT |  |
| Date Initiated by Firm | October 06, 2021 |
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| Create Date | November 02, 2021 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0193-2022 |
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| Recall Event ID |
88865 |
| 510(K)Number | K043546 |
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| Product Classification |
Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
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| Product | 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 |
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| Code Information |
UDI 00630414596754 |
| FEI Number |
2517506
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Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark
DE
19702-2466
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| For Additional Information Contact |
800-441-9250 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Software design |
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| 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 firmware upgrade. |
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| Quantity in Commerce | 1142 |
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| Distribution | Worldwide distribution. |
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| 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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| 510(K) Database | 510(K)s with Product Code = CDT
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