UniMatch Plus Software (2019-01-31)

Starting date:

January 31, 2019

Posting date:

February 15, 2019

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-69048

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  Reason
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  Affected products

Affected Products

UniMatch Plus Software

Reason

The UniMatch Plus Software that uses lot specific software catalog files (CHR_005_201807v1.uch) contain incorrect specificity information for lane 63, which may result in an ambiguous result or a mistyping. The impacted software catalog files were released and available for use between the date period Oct 12 2018 and Nov 15, 2018. Only files analyzed during this period are impacted. Worksheets for the accessory product are correct.

Affected products