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Recall Observatory FDA recall evidence

Device 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

Z-1316-2014

February 03, 2014

Class II

Product summary

Firm
Siemens Medical Solutions Diagnostics
Event
Event 67586
Status
Terminated
Classification
Class II
Quantity
1006 units
Official record key
device-enforcement:Z-1316-2014

Official wording

Reason: There is a potential for incorrect results to be reported from processing of a sample tube.

Code information: IMMULITE 2000: 10380062, 10380061,10380079, 10380065, 10360210, 10283632 IMMULITE 2000XPi: P010053/S007; 10373214 VersaCell: 10380063, 10389945, 10380064, 10287115, 10793839

Distribution pattern: Nationwide and Foreign Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for incorrect results to be reported from processing of a sample tube.