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.
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 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
Same manufacturer · Siemens Medical Solutions Diagnostics
See all →- ModerateSiemens Recalls Liquid Waste Bottles for Immulite 2000 Systems
FDA (Devices) · 2015-06-03
- ModerateSiemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings
FDA (Devices) · 2015-06-03
- ModerateSiemens Immulite 2000 Water Bottle Recall for Quality Defects
FDA (Devices) · 2015-06-03
- ModerateSiemens Medical Solutions Recalls Direct Water Feed Kits Due to Quality Issue
FDA (Devices) · 2015-06-03
- ModerateSiemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies
FDA (Devices) · 2015-06-03
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereExactech AcuMatch XLE Hip Implant Liner Recall
FDA (Devices) · 2025-02-19
- HighMEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
FDA (Devices) · 2024-12-11
Similar recalls
- HighSiemens IMMULITE 2000 XPi Analyzer Recalled for Tubing Crack Risk
FDA (Devices) · 2020-07-08
- HighSiemens Medical Solutions Recalls IMMULITE 2000 and VersaCell Diagnostic Instruments
FDA (Devices) · 2014-04-09
- HighSiemens IMMULITE 2000 Analyzer Recalled for Tubing Crack Hazard
FDA (Devices) · 2020-07-08
- HighSiemens Recalls Rubella IgM Assay Kits Due to False Positive Results
FDA (Devices) · 2016-10-19
- HighSiemens Recalls IMMULITE Assays Due to Biotin Interference Risk
FDA (Devices) · 2018-05-16
- HighSiemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results
FDA (Devices) · 2022-10-05