Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings
Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory 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, and the defect involves a mechanical failure (cap not closing) rather than a direct biological or chemical hazard, fitting the criteria for moderate severity.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling 962 bottles of Accessory Kits (Catalog #10282965, #10373217, and #10286080) used with Immulite 2000 and Immulite 2000XPi systems. These kits are used for in vitro diagnostic testing on 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 is undersized and/or deformed. This defect prevents the cap from closing or fastening securely to the bottle.
The affected products were distributed worldwide. Users should stop using the affected bottles and contact Siemens Medical Solutions Diagnostics for instructions on how to proceed.
The recalled product
- Product
- 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.
- Manufacturer
- Siemens Medical Solutions Diagnostics
- Hazard
- Affected units
- 962
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)
- Accessory Kit - Product Code/Catalog #'s 10282965
- 10373217 and 10286080
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 Medical Solutions Recalls Direct Water Feed Kits Due to Quality Issue
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- ModerateSiemens Recalls Liquid Waste Bottles for Immulite 2000 Systems
FDA (Devices) · 2015-06-03
- ModerateSiemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies
FDA (Devices) · 2015-06-03
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