Recall Z-1316-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Medical Solutions Diagnostics
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
| Date | Apr 2, 2014 (initiated Feb 3, 2014) |
| Status | Terminated |
| Reason | There is a potential for incorrect results to be reported from processing of a sample tube. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1006 units |
| Distribution | Nationwide and Foreign Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus, Apr 8, 1997 |