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Siemens Medical Solutions Diagnostics recalls IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that pe
Recalled April 9, 2014 · FDA recall Z-1316-2014 · Siemens Medical Solutions Diagnostics
Hazard
There is a potential for incorrect results to be reported from processing of a sample tube. · FDA Class II
Units
1006 units
Sold at
Nationwide and Foreign Distribution.
Description
There is a potential for incorrect results to be reported from processing of a sample tube.
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
Manufacturer(s)
Siemens Medical Solutions Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →