Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Part Number 775222

Starting date:

October 2, 2012

Posting date:

October 29, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15139

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  Reason
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  Affected products

Recalled Products:

Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Part Number 775222

Reason

The DXH SMS with software version 1.5.1.0 will not read Codabar labels at the primary barcode reader when the AIM-16 checksum digit calculation is used with any leading and trailing characters that are not both "a" (e.g. a12345b). The Codabar barcode symbology uses a single leading and trailing character as start and stop indicators, with characters such as a, b, c or d. when the Codabar symbology is used the labels can contain either matching or non-matching start and stop characters. If the character a is used for both the start and stop character (i.e. a12345a) the DXH SMS will read the bar code label successfully. If any other start and stop characters are used the system will produce no read from the primary barcode reader.

Affected products