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Terminated

UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

FDA Recall Z-0123-2013 · Posted 2012-10-24

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-09-03
Date Terminated2014-02-14
Product Quantity7 units total (both US and International)

Reason for Recall

Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Bar

Firm Action

Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest. For questions regarding this recall call 714-993-5321.

Root Cause

Software change control

Distribution Pattern

Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103842UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0Beckman Coulter, Inc. · 2011-04-27K060256UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMBeckman Coulter, Inc. · 2006-02-27K042291UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc. · 2004-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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