FDA-Device2015-06-03Class II
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi 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
186 bottles
Manufactured in
62 Flanders-Bartley Rd, Flanders, NJ, United States
Products
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi 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-1658-2015Don't want to check this manually?
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