Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies
Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be 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. The defect involves a mechanical fit issue (cap not closing securely) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a potential quality defect.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling Water Feed Kits (Catalog #10288216 and #10389714) used with Immulite 2000 and Immulite 2000XPi systems. These kits contain 8 bottles and are used for in vitro diagnostic testing with serum, plasma, or urine samples.
The recall is due to a manufacturing quality issue where the smaller diameter opening on the water bottles and liquid waste bottles may be undersized or deformed. This defect can prevent the cap from closing or fastening securely to the bottle.
The affected products were distributed worldwide. Users of these systems should stop using the recalled Water Feed Kits and contact Siemens Medical Solutions Diagnostics for further instructions.
The recalled product
- Product
- Water Feed Kit, Catalog#10288216,#10389714. 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.
- Manufacturer
- Siemens Medical Solutions Diagnostics
- Affected units
- 8
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)
- Water Feed Kit - Product Code/Catalog #'s 10288216 and 10389714
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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