Lysercell WDF (2018-06-25)

Starting date:

June 25, 2018

Posting date:

July 19, 2018

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-67266

• 
  Reason
• 
  Affected products

Affected products

Lysercell WDF

Reason

During an audit of manufacturing records for LYSERCELL WDF, it was discovered that a nonconforming raw material was incorrectly used to manufacture lot Y7034. LYSERCELL WDF is a lysing reagent that is used together with Fluorocell WDF stain to provide the counts and percentages of Neutrophils (Neut % and Neut#), Lymphocytes (lymph% and lymph#), Monocytes (Mono% and Mono#), and Eosinophils (Eo% and Eo#) on the Sysmex XN-series and XN-L Series of automated hematology analyzers. LYSERCELL WDF hemolyzes red blood cells and the Fluorocell WDF dye stains the white blood cells.

If the LYSERCELL WDF lot Y7035 is used, there may be an increase in false positive differential flags on patient samples. The specific flags are interpretive messages "Blasts/Abn Lympho" and "Atypical Lymph", which prompt the XN-Series operator to verify differential results by performing manual smear review. The quality control and reportable absolute cell counts and percentages are not affected.

Affected products