Siemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings
Siemens is recalling Liquid Waste Bottle Kits for Immulite 2000 systems because some bottle openings are undersized or deformed, preventing caps from closing securely.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a mechanical quality issue (undersized/deformed openings) that prevents secure cap fastening, without reported injuries or illnesses.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling the Liquid Waste Bottle Kit, Catalog #10386287, used with Immulite 2000 and 2000 XPi systems. These instruments perform chemiluminescent immunoassays on serum, plasma, or urine samples for in vitro diagnostic testing.
The recall is due to a quality issue where the smaller diameter opening on some Water Bottles and Liquid Waste Bottles is undersized and/or deformed. This defect prevents the cap from closing or fastening securely to the bottle.
The affected product was distributed worldwide. Users of the Immulite 2000 and 2000 XPi systems should check their Liquid Waste Bottle Kits for this defect and contact Siemens Medical Solutions Diagnostics for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Siemens Medical Solutions Diagnostics
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Liquid Waste Bottle Kit - Product Code/Catalog #10386287
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Siemens Medical Solutions Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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