# K970227: Immulite 2000 Automated Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Dpc Cirrus
- Decided: Apr 8, 1997 after 81 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200 (2004), 1 descendant of its own
- K160647: IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (2016), 0 descendants of its own
- K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform (2009), 0 descendants of its own
- K033234: Immulite 2500 Automated Immunoassay Analyzer (2003), 0 descendants of its own

## Recalls of this device
- May 15, 2020 · Class II · Z-2469-2020: 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
- May 15, 2020 · Class II · Z-2470-2020: 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
- Mar 5, 2015 · Class II · Z-1658-2015: 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 under
- Mar 5, 2015 · Class II · Z-1662-2015: 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 under
- Mar 5, 2015 · Class II · Z-1663-2015: 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 under
- Mar 5, 2015 · Class II · Z-1660-2015: 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 under
- Mar 5, 2015 · Class II · Z-1661-2015: 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 under
- Apr 25, 2014 · Class III · Z-1832-2014: The keyboard and monitor may not be properly secured to the monitor arm.
- Feb 3, 2014 · Class II · Z-1316-2014: There is a potential for incorrect results to be reported from processing of a sample tube.
- Oct 21, 2009 · Not classified · Z-1033-2010: 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 incompatibi
- May 15, 2009 · Not classified · Z-1891-2010: These substrate lots have shown a tendency to introduce a shift in both control and patient results with multiple methods.
- Jan 5, 2009 · Not classified · Z-1399-2009: Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.
- Apr 22, 2005 · Not classified · Z-0994-05: 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.

Source page: https://510kreport.com/device/K970227
Methodology: https://510kreport.com/methodology