Infinite F500 — Class II medical device recall Z-1967-2015

Terminated recall by Tecan US, Inc., reported 2015-07-08, distributed nationwide. A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

Recall number	`Z-1967-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Tecan US, Inc., Morrisville, NC, United States
Recall initiated	2015-05-29
Classified	2015-07-02
Reported by FDA	2015-07-08
Terminated	2017-08-18
Distributed	Nationwide (US)
Quantity	868 in
Reason classes	software
Serial numbers	`1003004146`, `1009002604`, `1009002605`, `1010001663`, `1103002583`, `1103003780`, `1109000103`, `1212004416`, `1308001035`, `1309003195`, `1311007600`, `1411007090`, `1412005124`, `1412005709`, `608000002`, `612000003`, `702000001`, `704000003`, `705007195`, `705009034`, `706004455`, `706007961`, `708000500`, `708005532`, `708005533` and 14 more

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1967-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.