Access Theophylline Immunoassay Reagents

• 2 recalls, same reason

  • Terminated Z-0309-2018 FDA Class III ·initiated 6 Nov 2017 ·on shared 510(k) K922823
  • Terminated Z-0308-2018 FDA Class III ·initiated 6 Nov 2017 ·on shared 510(k) K922823

  Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

• 3 recalls, same reason

  • Terminated Z-1711-2017 FDA Class II ·initiated 7 Mar 2017 ·on shared 510(k) K922823
  • Terminated Z-1710-2017 FDA Class II ·initiated 7 Mar 2017 ·on shared 510(k) K922823
  • Terminated Z-1709-2017 FDA Class II ·initiated 7 Mar 2017 ·on shared 510(k) K922823

  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 errors cause the instrument to stop running and cancel tests that are in process.

• • Terminated Z-1956-2016 FDA Class II ·initiated 17 May 2016 ·on shared 510(k) K922823

  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 until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.

• • Terminated Z-0984-2014 FDA Class II ·initiated 26 Nov 2013 ·on shared 510(k) K922823

  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.

• • Terminated Z-0291-2014 FDA Class II ·initiated 12 Sep 2013 ·on shared 510(k) K922823

  Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

• • Terminated Z-1032-2013 FDA Class II ·initiated 12 Feb 2013 ·on shared 510(k) K922823

  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 rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.

• • Terminated Z-0612-2013 FDA Class II ·initiated 1 Nov 2012 ·on shared 510(k) K922823

  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 an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.

• • Terminated Z-3126-2011 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011 ·on shared 510(k) K922823

  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 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i

• • Terminated Z-0607-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010 ·on shared 510(k) K922823

  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 missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.

• • Terminated Z-1372-2012 FDA Unclassified (pre-2012) ·initiated 11 Sep 2008 ·on shared 510(k) K922823

  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.

• • Terminated Z-2384-2008 FDA Unclassified (pre-2012) ·initiated 3 Apr 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 may negatively affect precision.

• • Terminated Z-1183-2008 FDA Unclassified (pre-2012) ·initiated 17 Oct 2007 ·on shared 510(k) K922823

  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.

• • Terminated Z-0265-05 FDA Unclassified (pre-2012) ·initiated 8 Nov 2004

  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 instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.

• • Terminated Z-1148-03 FDA Unclassified (pre-2012) ·initiated 18 Jun 2003 ·on shared 510(k) K922823

  Defective software media distributed with upgrade software may cause installation failure and systems lock.

• • Terminated Z-0692-03 FDA Unclassified (pre-2012) ·initiated 30 Jan 2003 ·on shared 510(k) K922823

  False results from secondary pour off tubes

• • Terminated Z-0619-03 FDA Unclassified (pre-2012) ·initiated 27 Jan 2003 ·on shared 510(k) K922823

  Spring failure, design defect in component.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K922823 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Kallestad Rsv Microplate Eia

  Class I

  FDA 510(k) K924289 Active Cleared 12 Feb 1993

• Access(R) Total Ige Assay

  Class II

  FDA 510(k) K930984 Active Cleared 9 Jun 1993

• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

  FDA 510(k) K963934 Active Cleared 16 Dec 1996

• Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

  Class II

  FDA 510(k) K041658 Active Cleared 20 Dec 2004

• Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and Bi

  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

See all devices from Bio-Rad Laboratories, Inc. →

• What clinical setting or type of laboratory is this immunoassay reagent designed for use in?

  The Access Theophylline Immunoassay Reagents are specifically designed for use in clinical chemistry laboratories, particularly those equipped with automated immunoassay analyzers. This system is intended for quantitative measurement of theophylline levels in serum or plasma samples, making it suitable for monitoring patients with respiratory conditions like asthma or COPD who are on theophylline therapy.

• How is this reagent system supplied, and what components are included in the kit?

  The Access Theophylline Immunoassay Reagents are supplied as a complete kit, containing all necessary components for performing the assay. This includes reagents, calibration standards, and controls required to run the immunoassay on an automated analyzer. The kit is designed to streamline the testing process in clinical chemistry labs.

• Is this reagent system intended for single-use or can it be reused across multiple tests?

  The provided data does not explicitly state whether the reagents are single-use or reusable. However, immunoassay reagents like these are typically designed for multiple tests within the kit’s shelf life, provided they are stored and handled according to manufacturer guidelines. Always refer to the manufacturer’s instructions for specific usage details.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  The Access Theophylline Immunoassay Reagents received a Traditional 510(k) clearance (K922823) from the FDA under the classification of a Class II medical device (21 CFR 862.1295). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements for its intended use in clinical chemistry laboratories.

• Are there any specific storage requirements mentioned for this reagent system?

  The provided data does not include explicit storage instructions for the Access Theophylline Immunoassay Reagents. Typically, immunoassay reagents require refrigeration or specific temperature conditions to maintain stability and performance. For accurate storage guidelines, consult the manufacturer’s labeling or accompanying documentation.