Home / Recalls / Siemens Medical Solutions Diagnostics / Z-1662-2015

Z-1662-2015 Class II Terminated

Recalled by Siemens Medical Solutions Diagnostics — Flanders, NJ

Recall Details

Product Type
Devices
Report Date
June 3, 2015
Initiation Date
March 5, 2015
Termination Date
January 16, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 bottles

Product Description

Water Feed Kit, Catalog#10288216,#10389714. 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.

Reason for Recall

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

Distribution Pattern

Worldwide Distribution.

Code Information

Water Feed Kit - Product Code/Catalog #'s 10288216 and 10389714

Other recalls by Siemens Medical Solutions Diagnostics

  • 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)
  • Z-1316-2014 Class II — IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are cont (February 3, 2014)