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Immulite 2000 Automated Immunoassay Analyzer

by Dpc Cirrus 510(k)

Active United States

510(k) K970227

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970227 Date8 Apr 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

13 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2470-2020 FDA Class II initiated 15 May 2020
    • Terminated Z-2469-2020 FDA Class II initiated 15 May 2020

    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

  • 5 recalls, same reason

    • Terminated Z-1663-2015 FDA Class II initiated 5 Mar 2015
    • Terminated Z-1661-2015 FDA Class II initiated 5 Mar 2015
    • Terminated Z-1660-2015 FDA Class II initiated 5 Mar 2015
    • Terminated Z-1658-2015 FDA Class II initiated 5 Mar 2015
    • Terminated Z-1662-2015 FDA Class II initiated 5 Mar 2015

    The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

    • Terminated Z-1832-2014 FDA Class III initiated 25 Apr 2014 via K970227, on the same 510(k)

    The keyboard and monitor may not be properly secured to the monitor arm.

    • Terminated Z-1316-2014 FDA Class II initiated 3 Feb 2014

    There is a potential for incorrect results to be reported from processing of a sample tube.

    • Terminated Z-1033-2010 FDA Unclassified (pre-2012) initiated 21 Oct 2009 via K970227, on the same 510(k)

    The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units) due to incompatibility of the Toxoplasma IgM kits with this particular lot of IgG/IgM Sample Diluent. All available lots of the IMMULITE 2000/2500 Toxoplasma IgM kits (L2KTM/L5KTM) are incompatible with Diluent lot 150

    • Terminated Z-1891-2010 FDA Unclassified (pre-2012) initiated 15 May 2009

    These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.

    • Terminated Z-1399-2009 FDA Unclassified (pre-2012) initiated 5 Jan 2009 via K970227, on the same 510(k)

    Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

    • Terminated Z-0994-05 FDA Unclassified (pre-2012) initiated 22 Apr 2005

    The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
JJE
Device Class
Class I
Regulation
21 CFR Part 862.2160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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