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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

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