Company: One Lambda Inc
Date of Enforcement Report: 6/19/2019
Class II
PRODUCT
UniMatch Plus Software (Catalog ID 790111 and A10286, Version 6.0) when used in association with CHR_005_201807v1.uch
Recall Number: B-0675-2019
REASON
The UniMatch Plus Software, containing incorrect allele specificity information, which may result in an ambiguous result or a mistyping, was distributed.
RECALLING FIRM/MANUFACTURER
One Lambda Inc on 2/1/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
700 devices
DISTRIBUTION
US Nationwide and Interational