Recall – Software error may result in ambiguous results

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.