Home / Recalls / Siemens Medical Solutions Diagnostics / Z-1316-2014

Z-1316-2014 Class II Terminated

Recalled by Siemens Medical Solutions Diagnostics — Flanders, NJ

Recall Details

Product Type
Devices
Report Date
April 9, 2014
Initiation Date
February 3, 2014
Termination Date
June 30, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1006 units

Product Description

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 for Recall

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

Distribution Pattern

Nationwide and Foreign Distribution.

Code Information

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

Other recalls by Siemens Medical Solutions Diagnostics

  • Z-1662-2015 Class II — Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are con (March 5, 2015)
  • Z-1658-2015 Class II — Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi sy (March 5, 2015)
  • Z-1660-2015 Class II — Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 syste (March 5, 2015)
  • Z-1663-2015 Class II — Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi sys (March 5, 2015)
  • Z-1661-2015 Class II — Direct Water feed Kit, Catalog#10373222 (March 5, 2015)
  • Z-1659-2015 Class II — Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuo (March 5, 2015)
  • Z-1832-2014 Class III — VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory samp (April 25, 2014)