Recall Z-0940-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
| Date | Feb 9, 2014 (initiated Nov 6, 2013) |
| Status | Terminated |
| Reason | The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC). |
| Root cause | Software design |
| Action | Siemens sent an Urgent Medical Device Correct letter, dated November 6, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain the recall notification letter with their laboratory records and forward to those who may have received the affected product. |
| Quantity | 3759 |
| Distribution | Worldwide Distribution and USA Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |