FDA-Device2015-06-03Class II
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.
Siemens Medical Solutions Diagnostics
Hazard
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.
Sold states
Worldwide Distribution.
Affected count
8 bottles
Manufactured in
62 Flanders-Bartley Rd, Flanders, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1662-2015Don't want to check this manually?
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