Product Wiki · Recalls · Health Canada — Medical Devices

Coulter LH and Unicel DXH Slidestainer / Slidemakers (2013-10-23) — recall 50308

Health Canada — Medical Devices · Canada · 2013-11-29 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50308
Date of alert
2013-11-29
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Beckman Coulter has confirmed slide staining irregularities being experienced by some customers using Beckman Coulter DXH and LH Slides with Coulter Trucolor stains and buffers. Customers have reported stain irregularities with the use of the slides, stains, and buffers listed above,including: Red blood cells that appear hypochromic, refractile or punched out. Excess precipitate that may be interpreted as increased cellular granularity in white blood cells, inclusions in red blood cells and/or particles that interfere with platelet estimates. A dark blue/purple background stain that may interfere with the ability to read the slides.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/coulter-lh-and-unicel-dxh-slid

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