Unicel DXH 600 and DXH 800 Systems (2013-11-08)

Starting date:

November 8, 2013

Posting date:

December 4, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36995

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  Reason
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  Affected products

Recalled products

1. Unicel DXH 800 Coulter Cellular Analysis System
2. Unicel DXH 600 Coulter Cellular Analysis System

Reason

Complaints related to optical degredation have increased on the DXH 800 and DXH 600 systems. Customers have reported that they are experiencing an increase in one or more of the following: (1) Flow cell clogs; (2) ls offset errors during daily check or control analysis; (3) High coefficients of variation for Latron CP-X controls for low angle light scatter and/or axial light loss parameters; (4) System messages and R-Flagged results for NRBC, Diff and Retic during control or patient analysis, such as partial clogs (Low event rated with Diff RS) or a voltage failure (System event: D with Diff RS).

Affected products