Z-0914-2010

Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access...

Name: Z-0914-2010 Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access...
Creator: Beckman Coulter Inc.
Published: 2008-10-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-10-09 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access... on 2008-10-09. The reason FDA records is "The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect...". 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-0914-2010
Status: Terminated
Initiated: 2008-10-09
Posted: 2010-03-02
Terminated: 2012-05-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed ab
Root cause tag: manufacturing process
FDA root cause: Other
Action: Beckman Coulter contacted consignees via "Urgent Product Corrective Action" letter dated October 16, 2008 to inform them of the recall and to arrange a date to service the affected product as soon as possible. For further information, contact Beckman Coulter: (a)In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at www.beckman.com/customersupport. (b) Outside the U.S.A. and Canada, contact your technical support representative.
Quantity in commerce: 107 (US), 7 (OUS)
Distribution: Worldwide Distribution -- United States and Canada.
Product codes and lots: Pump Part Numbers A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers: 973100, A30260, and A59102.

Product code JJE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)