Tecan US, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1967-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.

Product Classification:

Class II

Date Initiated: May 29, 2015

Date Posted: July 8, 2015

Recall Number: Z-1967-2015

Event ID: 71352

Reason for Recall:

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

Status: Terminated

Product Quantity: 868 in total

Code Information:

Material Number 30019337. Serial numbers 1212004416 1009002605 612000003 811002510 712004158 906000965 902005109 912003472 1103002583 1411007090 704000003 702000001 708000500 1003004146 1109000103 1412005124 805001219 911005026 708005532 705007195 810000248 1010001663 712004152 708005533 1412005709 1103003780 706004455 608000002 908000185 1009002604 1308001035 804005914 1311007600 804000984 705009034 1309003195 801008055 706007961 901006341

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated