# K922823: Access Theophylline Immunoassay Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Aug 5, 1992 after 55 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K121214: Access Accutni+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2 Immunoassay System (2013), 8 descendants of its own
- K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100 (2003), 6 descendants of its own
- K172787: Access hsTnl (2018), 4 descendants of its own
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own

## Recalls of this device
- Nov 6, 2017 · Class III · Z-0308-2018: 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: 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: 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
- Mar 7, 2017 · Class II · Z-1710-2017: 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
- Mar 7, 2017 · Class II · Z-1711-2017: 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
- May 17, 2016 · Class II · Z-1956-2016: 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
- Nov 26, 2013 · Class II · Z-0984-2014: 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 incorrec
- Sep 12, 2013 · Class II · Z-0291-2014: 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: 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 caus
- Nov 1, 2012 · Class II · Z-0612-2013: 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
- Apr 15, 2011 · Not classified · Z-3126-2011: 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
- Aug 13, 2010 · Not classified · Z-0607-2011: 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 
- Sep 11, 2008 · Not classified · Z-1372-2012: 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: 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
- Oct 17, 2007 · Not classified · Z-1183-2008: 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 s
- Nov 8, 2004 · Not classified · Z-0265-05: 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 Bl
- Jun 18, 2003 · Not classified · Z-1148-03: Defective software media distributed with upgrade software may cause installation failure and systems lock.
- Jan 30, 2003 · Not classified · Z-0692-03: False results from secondary pour off tubes
- Jan 27, 2003 · Not classified · Z-0619-03: Spring failure, design defect in component.

Source page: https://510kreport.com/device/K922823
Methodology: https://510kreport.com/methodology