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

Recall Insight

This FDA Devices action (record #Z-2469-2020) was formally reported on July 8, 2020, with the manufacturer initiating the action on May 15, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics Inc. is listed as the recalling firm, operating out of Flanders, NJ. Federal records list the affected scope as 1555 units.

The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of AE, AO, AR, AT, AU, AZ, BA, BD, BE, BG, BH, BO, BR, BS, BY, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GP, GR, HK, HR…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.