FDA Recall Terminated

Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.

Recall: Z-1970-2015 · Initiated May 29, 2015

Recall

Recall Number
Z-1970-2015
Event Number
71352
Firm
Tecan US, Inc.
FEI Number
1037985
Product Code
KHO
Status
Terminated
Root Cause
Device Design
Initiated
May 29, 2015
Posted
July 2, 2015
Terminated
August 18, 2017
Address
9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560

Description

Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.

Reason

A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

Action

Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.

Distribution

US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC

Quantity

868 in total