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Siemens Medical Solutions Diagnostics recalls Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instr
Recalled June 3, 2015 · FDA recall Z-1658-2015 · 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. · FDA Class II
Units
186 bottles
Sold at
Worldwide Distribution.
Description
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.
Product
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.
Manufacturer(s)
Siemens Medical Solutions Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →