Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human
FDA device recall Z-0800-2014 · posted 2014-01-21 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
- Action taken
- The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1563
- Distribution
- Worldwide Distribution. USA nationwide and the country of Canada.
- Date initiated
- 2013-12-17
- Date posted
- 2014-01-21
- Date terminated
- 2014-08-26
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |