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.
FDA Recall Z-1183-2008 · Posted 2008-08-20
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Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2007-10-17
Date Terminated2012-04-27
Product Quantity3055 instruments in the US; 192 instruments in Canada
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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