510(k) · Cleared
Recalled · Class II · 2020Immulite 2000 Automated Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dpc Cirrus · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Apr 8, 1997 after an 81-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 13 times.
- Decided
- Apr 8, 1997
- Review
- 81 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 13
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK970227 Immulite 2000 Automated Immunoassay AnalyzerDpc Cirrus · 1997
- Descendant · cites it directly · 1 of its ownK041658 Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK160647 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK083080 Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics…Sqi Diagnostics Systems · 2009
- Descendant · cites it directly · 0 of its ownK033234 Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 2003 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K041658Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…Bio-Rad Laboratories, Inc. · 2004 · cites it directly1descendant
- K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2016 · cites it directly0descendants
- K083080Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics PlatformSqi Diagnostics Systems · 2009 · 2 generations on0descendants
- K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970227 | Immulite 2000 Automated Immunoassay Analyzer | Dpc Cirrus | 1997 | — |
| +1 | K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories, Inc. | 2004 | 1 |
| +1 | K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +2 | K083080 | Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform | Sqi Diagnostics Systems | 2009 | — |
| +1 | K033234 | Immulite 2500 Automated Immunoassay Analyzer | Diagnostic Products Corp. | 2003 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2020 | Class II | Z-2469-2020 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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… |
| Mar 5, 2015 | Class II | Z-1662-2015 | Nonconforming Material/Component | 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… |
| Mar 5, 2015 | Class II | Z-1663-2015 | Nonconforming Material/Component | 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… |
| Mar 5, 2015 | Class II | Z-1660-2015 | Nonconforming Material/Component | 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… |
| Mar 5, 2015 | Class II | Z-1661-2015 | Nonconforming Material/Component | 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… |
| Apr 25, 2014 | Class III | Z-1832-2014 | Device Design | The keyboard and monitor may not be properly secured to the monitor arm. |
| Feb 3, 2014 | Class II | Z-1316-2014 | Device Design | There is a potential for incorrect results to be reported from processing of a sample tube. |
| Oct 21, 2009 | Not classified | Z-1033-2010 | Nonconforming Material/Component | 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… |
| May 15, 2009 | Not classified | Z-1891-2010 | Device Design | 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 | Process design | 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 | Other | 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. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041658 (Bio-Rad Laboratories, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
https://510kreport.com/device/K970227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970227: Immulite 2000 Automated Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970227
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026