Products: lab-automation. Risk band: Low RobotRisk index 7.3/100 (incidents/exposure, time-weighted) · 89th percentile of 162 medical robotics companies.
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. The index of 7.4 and percentile of 88.8 place the company high within the medical-robotics category, reflecting a multi-year recurrence of regulatory recalls rather than a single event. 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.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 07/25 2016 |
recall | — | FDA Class II recall: SUNRISE instrument. · SUNRISE instrument. | openFDA enforcement |
| S3 | 05/29 2015 |
recall | — | FDA Class II recall: Infinite F500, in vitro diagnostic. · Infinite F500, in vitro diagnostic. | openFDA enforcement |
| S2 | 11/10 2014 |
recall | — | FDA Class III recall: Infinite 200PRO · Infinite 200PRO | openFDA enforcement |