IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perfo
FDA device recall Z-1316-2014 · posted 2014-04-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- There is a potential for incorrect results to be reported from processing of a sample tube.
- Action taken
- Siemens sent an Urgent Medical Device Correction letter dated February 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers was told how to correct the issue if it has occurred, and how to prevent the issue from occurring. The completed form should be faxed to (302) 631-7597. Any questions can be directed to Siemens Technical Support Representative. Siemens plans to implement a correction at a later time.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1006 units
- Distribution
- Nationwide and Foreign Distribution.
- Date initiated
- 2014-02-03
- Date posted
- 2014-04-02
- Date terminated
- 2016-06-30
- Location
- Flanders, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227) | Dpc Cirrus | 1997-04-08 |