Siemens Healthcare Diagnostics Inc.: Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard

Agency Publication Date: June 29, 2020

Affected Products

Product: Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.

Serial numbers B0058 through S5970

Product: Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.

Serial numbers A001 through M5295

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85731

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics Inc.

Manufactured In: United States

Units Affected: 2 products (1555 units; 2925 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Medium RiskFDA Device