Tecan

Products: lab-automation. Risk band: Low RobotRisk index 12.1/100 (severity- and time-weighted incidents) · ranked 20 of 25 among Medical robotics companies with incidents (173 tracked).

Analyst brief

Tecan's record shows three entries spanning 2014 to 2016, all FDA recalls of laboratory/diagnostic instruments: a Class III recall of the Infinite 200PRO (severity 2) in 2014, a Class II recall of the Infinite F500 in vitro diagnostic system (severity 3) in 2015, and a Class II recall of the SUNRISE instrument (severity 3) in 2016. Tecan's index of 12.1 ranks 20 of 25 companies in Medical robotics with incident history. The record is entirely regulator-driven, consisting exclusively of FDA recall classifications with no press-originated incidents. The pattern shows repeated product-quality actions on laboratory automation equipment over a three-year span, with severity concentrated in the low-to-moderate FDA recall classes rather than injury or fatality events.

Risk index

12.1/100RobotRisk index

22.1/100Median index across the 25 Medical robotics companies with incident history (173 tracked, 148 with none)

20 of 25Rank in Medical robotics (of 25 with incident history)

LowRisk band

Incident timeline

Comparisons over time

Per-type breakdown

Incident type	Unique incidents	Share
recall	3	100%

Unique incident list

3 unique incidents on file for this company.

Sev	Date	Type	Location	Incident	Source
S3	25 Jul 2016	recall	—	FDA Class II recall: SUNRISE instrument. · SUNRISE instrument.	openFDA enforcement
S3	29 May 2015	recall	—	FDA Class II recall: Infinite F500, in vitro diagnostic. · Infinite F500, in vitro diagnostic.	openFDA enforcement
S2	10 Nov 2014	recall	—	FDA Class III recall: Infinite 200PRO · Infinite 200PRO	openFDA enforcement