Z-1183-2008

Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay...

Name: Z-1183-2008 Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay...
Creator: Beckman Coulter Inc
Published: 2007-10-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-10-17 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC... on 2007-10-17. The reason FDA records is "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". 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-1183-2008
Status: Terminated
Initiated: 2007-10-17
Posted: 2008-08-20
Terminated: 2012-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers. The customers were informed that 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. The letter referenced a proactive initiative to inspect the power supply sled assemblies on all instruments referenced. A response form was included.
Quantity in commerce: 3055 instruments in the US; 192 instruments in Canada
Distribution: Nationwide Distribution and Canada
Product codes and lots: Part Number A48196/6845C; Instrument part numbers 81600 and 81600N

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