FDA-Device2014-04-09Class II
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
Siemens Medical Solutions Diagnostics
Hazard
There is a potential for incorrect results to be reported from processing of a sample tube.
Sold states
Nationwide and Foreign Distribution.
Affected count
1006 units
Manufactured in
62 Flanders-Bartley Rd, N/A, Flanders, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief