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.

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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.