Liquid Waste Bottle Kit, Catalog#10386287. 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.
This recall has been terminated (originally issued May 23, 2015).
- Recall Initiated
- March 5, 2015
- Posted
- May 23, 2015
- Terminated
- January 16, 2018
- Recall Number
- Z-1663-2015
- Quantity
- 15 bottles
- Firm Location
- Flanders, NJ
- Official Source
- View on FDA website ↗
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
Worldwide Distribution.
Lot / Code Info
Liquid Waste Bottle Kit - Product Code/Catalog #10386287
Root Cause
Nonconforming Material/Component
Action Taken
Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
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