19
Jun
2019

Recall – Software error may result in ambiguous results

,
0

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

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