Health product recall

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

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

UniMatch Plus Software

Lot or serial number

CHR_005_201807v1.uch

Model or catalog number

A10286

Companies
Manufacturer
One Lambda Inc
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES