Siemens Immulite 2000 Water Bottle Recall for Quality Defects
Siemens Medical Solutions Diagnostics is recalling 186 Immulite 2000 water bottles because the openings may be undersized or deformed, preventing caps from closing securely.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is a quality issue that prevents secure fastening, which fits the criteria for moderate severity without reported injuries or high-risk pathogens.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling 186 water bottles (Catalog #10380062, #10291586) used with the Immulite 2000 and 2000 XPi systems. These instruments are continuous random-access devices that perform chemiluminescent immunoassays using serum, plasma, or urine samples for in vitro diagnostic testing.
The recall is due to a manufacturing quality issue where the smaller diameter opening on the 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 bottles were distributed worldwide. Users of the Immulite 2000 and 2000 XPi systems should check their water bottles for these defects and contact Siemens Medical Solutions Diagnostics for instructions on how to proceed.
The recalled product
- Product
- Water bottles, Catalog#10380062, #10291586. 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
- 186
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 (2)
- (Water Bottle) - Product Code #10380062
- Catalog #10291586
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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- ModerateSiemens Recalls Liquid Waste Bottles for Immulite 2000 Systems
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- ModerateSiemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies
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