Z-1967-2015Class II

Infinite F500, in vitro diagnostic

Name: Z-1967-2015 Infinite F500, in vitro diagnostic
Creator: Tecan US, Inc.
Published: 2015-05-29
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2015-05-29 / Terminated / root cause: design

FDA source

Tecan US, Inc. began a recall of Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500... on 2015-05-29. FDA classified it as Class II and gives the reason as "A firmware bug causes incorrect values to be displayed for specific measured luminescence values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1967-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-07-02
Terminated: 2017-08-18
Recalling firm: Tecan U.S.
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.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Root cause tag: design
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1967-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1967-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1968-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1969-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1970-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1971-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code KHO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)