Siemens Recalls Liquid Waste Bottles for Immulite 2000 Systems
Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles for Immulite 2000 systems due to a quality issue where the opening may be undersized or deformed, preventing the cap 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 opening) that prevents secure closure. No injuries, illnesses, or specific high-risk hazards are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles, Catalog #10291587, used with Immulite 2000 and Immulite 2000XPi systems. These systems are continuous random-access instruments 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 bottles may be undersized or deformed. This defect can prevent the cap from closing or fastening securely to the bottle.
The affected bottles were distributed worldwide. No specific instructions for consumers are provided in the source text, but the defect relates to the secure closure of the waste bottle.
The recalled product
- Product
- Liquid Waste Bottle, Catalog#10291587. 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
- 231
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) -Product Code/ Catalog #10291587
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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