RobotRisk › Tecan › 29 May 2015

FDA Class II recall: Infinite F500, in vitro diagnostic.

S3 · 29 May 2015 · Tecan

Record

Company	Tecan
Industry	Medical robotics
Type(s)	recall
Date	29 May 2015 (day precision)
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	(recall, enforcement, or fleet-wide fault)
Scale	Infinite F500, in vitro diagnostic.
Confidence	high
Verified flag	Yes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-1967-2015): A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)

Date	Supporting source row	Publisher	Link
29 May 2015	FDA Class II recall: Infinite F500, in vitro diagnostic.	openFDA enforcement	openFDA enforcement

Tecan other incidents timeline

Medical robotics context

recall context

Tecan industry position

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