510(k) · Cleared
Recalled · Class II · 2017Access Theophylline Immunoassay Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · CGN Acid, Folic, Radioimmunoassay
Cleared on Aug 5, 1992 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled 19 times.
- Decided
- Aug 5, 1992
- Review
- 55 days
- Class
- Class II
- Product code
- CGN
- Recalls
- 19
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK922823 Access Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. · 1992
- Descendant · cites it directly · 8 of its ownK121214 Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on…Beckman Coulter, Inc. · 2013 · Recalled
- Descendant · cites it directly · 6 of its ownK023764 Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK172787 Access hsTnlBeckman Coulter, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
2003high 3 (2025) · low 0 (2004)2026
Most influential descendants
Showing 5 of 16 · See all- K121214Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…Beckman Coulter, Inc. · 2013 · cites it directly8descendants
- K023764Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. · 2003 · cites it directly6descendants
- K172787Access hsTnlBeckman Coulter, Inc. · 2018 · 2 generations on4descendants
- K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · 2 generations on4descendants
- K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922823 | Access Theophylline Immunoassay Reagents | Bio-Rad Laboratories, Inc. | 1992 | — |
| +1 | K121214 | Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the… | Beckman Coulter, Inc. | 2013 | 5 |
| +1 | K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100 | Beckman Coulter, Inc. | 2003 | 31 |
| +2 | K172787 | Access hsTnl | Beckman Coulter, Inc. | 2018 | 1 |
| +2 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| +3 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 CGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGN device
- #1 K233060 Elecsys Folate IIIscore 9.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 162 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 |
|---|---|---|---|---|
| Nov 6, 2017 | Class III | Z-0308-2018 | Device Design | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. |
| Nov 6, 2017 | Class III | Z-0309-2018 | Device Design | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. |
| Mar 7, 2017 | Class II | Z-1709-2017 | Software Design Change | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position… |
| Mar 7, 2017 | Class II | Z-1710-2017 | Software Design Change | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position… |
| Mar 7, 2017 | Class II | Z-1711-2017 | Software Design Change | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position… |
| May 17, 2016 | Class II | Z-1956-2016 | Under Investigation by firm | Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results… |
| Nov 26, 2013 | Class II | Z-0984-2014 | Nonconforming Material/Component | The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results. |
| Sep 12, 2013 | Class II | Z-0291-2014 | Mixed-up of materials/components | Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage. |
| Feb 12, 2013 | Class II | Z-1032-2013 | Device Design | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley… |
| Nov 1, 2012 | Class II | Z-0612-2013 | Device Design | It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at… |
| Apr 15, 2011 | Not classified | Z-3126-2011 | Other | The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4… |
| Aug 13, 2010 | Not classified | Z-0607-2011 | Pending | This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of… |
| Sep 11, 2008 | Not classified | Z-1372-2012 | Software design | The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay. |
| Apr 3, 2008 | Not classified | Z-2384-2008 | Nonconforming Material/Component | The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision. |
| Oct 17, 2007 | Not classified | Z-1183-2008 | Process control | Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering. |
| Nov 8, 2004 | Not classified | Z-0265-05 | Other | A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The… |
| Jun 18, 2003 | Not classified | Z-1148-03 | Other | Defective software media distributed with upgrade software may cause installation failure and systems lock. |
| Jan 30, 2003 | Not classified | Z-0692-03 | Other | False results from secondary pour off tubes |
| Jan 27, 2003 | Not classified | Z-0619-03 | Other | Spring failure, design defect in component. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121214 (Beckman Coulter, Inc., 2013) has gone furthest, with 8 descendants of its own.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGN
1in 2024
2007high 2 (2009) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · CGN
Too few CGN 510(k)s in any year since 2007 to give a median.
Recalls per year · CGN
3in 2019
2007high 3 (2019) · low 0 (2011)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGN
9in 2025
2007high 28 (2011) · low 0 (2008)2025
MAUDE reports naming product code CGN, 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 | — | 2 | 26 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 28 |
| 2012 | 0 | — | 2 | 11 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 2 | 2 |
| 2019 | 0 | — | 3 | 1 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K922823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922823: Access Theophylline Immunoassay Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922823
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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