Bekman Coulter AU Immunochemistry System-AU480 (2013-09-03)

Starting date:

September 3, 2013

Posting date:

September 16, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-41383

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  Reason
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  Affected products

Recalled products

1. Bekman Coulter AU Immunochemistry System-AU480

Reason

When the AU480 Clinical Chemistry Analyzer operates using the real-time online function, and the number of barcode digits in the sample ID barcode label does not match the instrument configuration setting in the "requisition format" menu and in the LIS system, the AU480  Clinical Chemistry Analyzer generates alarm 6042 "online mismatch" and the sample is not processed. If the number of barcode digits configured in the LIS, middle ware, and AU480 settings match, the customer will not experience the issue. The issue does not generate incorrect results but may cause a delay in processing the sample.

Affected products