LABType Typing Tests (2016-09-29)

Starting date:

September 29, 2016

Posting date:

November 9, 2016

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-60944

• Reason
• Affected products

Affected Products

A. LABTYPE SSO CLASS II DRB1 TYPING TEST & LABTYPE HD CLASS II DRB1 TYPING TEST
B. LABTYPE SSO MICA
C. LABTYPE SSO CLASS I BW4 SUPPLEMENT TYPING TEST
D. LABTYPE SSO CLASS II DQA1/DQB1 TYPING TEST

Reason

Lot specific user documents and catalog files updated for January 2016 nomenclature contain incorrect allele specificity information for certain beads which may result in mistyping.  The impacted worksheets and catalog files were released and available for use between the date period July 29, 2016 to August 22, 2016.  Only files analyzed during this period are impacted.  Contact manufacturer for specific lot and batch numbers and details.

Affected products