Z-0619-03

Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use

Name: Z-0619-03 Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use
Creator: Beckman Coulter Inc
Published: 2003-01-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-01-27 / Terminated / root cause: design

FDA source

Beckman Coulter Inc began a recall of Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use on 2003-01-27. The reason FDA records is "Spring failure, design defect in component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0619-03
Status: Terminated
Initiated: 2003-01-27
Posted: 2003-03-06
Terminated: 2003-10-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Spring failure, design defect in component.
Root cause tag: design
FDA root cause: Other
Action: A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment)
Quantity in commerce: 2418
Distribution: Product has been distributed in US from 8/92 to present. All these units are affected.
Product codes and lots: Not applicable.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)