Z-1660-2015 Class II Terminated
FDA device recall Z-1660-2015 was initiated by Siemens Medical Solutions Diagnostics on March 5, 2015 and is designated Class II. 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 under… The recall status is terminated (terminated January 16, 2018). Affected quantity: 962 bottles.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2015
- Initiation Date
- March 5, 2015
- Termination Date
- January 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 962 bottles
Product Description
Accessory Kit, Catalog#10282965, #10373217,#10286080. 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.
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 Pattern
Worldwide Distribution.
Code Information
Accessory Kit - Product Code/Catalog #'s 10282965, 10373217 and 10286080