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Infinite F50 ROBOTIC

Tecan Austria GmbH · Model 30087509 01 · UDI-DI 09120052070422

JJQ
10
510(k) clearances
355
Adverse events (1 deaths)
17
Recalls
88
Facilities

Description

The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software. It is intended to be integrated in robotic solutions.

Recalls

DateFirmReason
2025-09-23Becton Dickinson & Co.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar
2022-10-03Beckman Coulter, Inc.Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2011-01-12QIAGEN Gaithersburg, Inc.The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
2009-03-12BioTek Instruments, Inc.Software design allowed false negatives to be read when wells are dark.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.