Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200,
FDA device recall Z-0940-2014 · posted 2014-02-09 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 3759
- Distribution
- Worldwide Distribution and USA Nationwide.
- Date initiated
- 2013-11-06
- Date posted
- 2014-02-09
- Date terminated
- 2015-08-10
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |