FDAFDA · Food and drugs·Recall number Z-1660-2015
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.
Published June 3, 2015 · Recall initiated: March 5, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions Diagnostics
- Distributor
- Worldwide Distribution.
- Lot
- Accessory Kit - Product Code/Catalog #'s 10282965, 10373217 and 10286080
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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