Device 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.
Z-1658-2015
Product summary
- Event
- Event 71022
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186 bottles
- Official record key
device-enforcement:Z-1658-2015
Official wording
Reason: 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.
Code information: (Water Bottle) - Product Code #10380062; Catalog #10291586
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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.