FDA Device recall Z-1316-2014
IMMULITE 2000
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of IMMULITE 2000 by Siemens Medical Solutions Diagnostics, citing there is a potential for incorrect results to be reported from processing of a sample tube.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1316-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-03 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Diagnostics |
| Distribution | US |
Product
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
Reason
There is a potential for incorrect results to be reported from processing of a sample tube.
Identifiers
| code_info | IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 1037…IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1316-2014%22
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