Cl III TANGO Infinity

Company: Bio-Rad Laboratories, Inc.
Date of Enforcement Report 9/7/2016
Class lII:

PRODUCT

TANGO Infinity, catalog # 850000010, Software version 1.2
Recall Number B-0746-16

REASON
TANGO Infinity System, with a defect or glitch allowing an incorrect microplate type, was distributed.

RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc. , Redmond, WA on 9/1/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20 devices

DISTRIBUTION
CA, FL, GA, MA, MD, MN, NC, NY, PA, TX, VA and WA DC.

___________________________________

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.