Z-0984-2014Class II

Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for...

Name: Z-0984-2014 Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for...
Creator: Beckman Coulter Inc.
Published: 2013-11-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-11-26 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or... on 2013-11-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0984-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2014-02-16
Terminated: 2014-07-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Product codes and lots: Part Number 81600N. Serial Numbers 508957, 508963, 508964.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-16
Z-0985-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-16

Product code JJE

K922823Class IIAccess Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. / cleared 1992-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)