FDA Medical Device Recalls (openFDA)
Tecan US, Inc.: 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.
- Recall number
- Z-1967-2015
- Recalling firm
- Tecan US, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-05-29
- Posted
- 2015-07-02
- Terminated
- 2017-08-18
- Reason
- A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
- Root cause
- Device Design
- 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.
- Quantity
- 868 in total
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KHO
- Firm FEI
- 1037985
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28