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SUNRISE-RC/ST EVOLYZER
Tecan Austria GmbH · Model 30087504 02 · UDI-DI 09120052071191
10
510(k) clearances
355
Adverse events (1 deaths)
17
Recalls
88
Facilities
Description
microplate reader - intended to be integrated in robotic solutions
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Becton 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 |
| 2022-10-03 | Beckman Coulter, Inc. | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. |
| 2016-07-25 | Tecan US, Inc. | The batteries have the potential to overheating, melt or char. |
| 2016-07-25 | Tecan US, Inc. | The batteries have the potential to overheating, melt or char. |
| 2016-07-25 | Tecan US, Inc. | The batteries have the potential to overheating, melt or char. |
| 2016-07-25 | Tecan US, Inc. | The batteries have the potential to overheating, melt or char. |
| 2016-07-25 | Tecan US, Inc. | The batteries have the potential to overheating, melt or char. |
| 2016-07-25 | Tecan US, Inc. | The batteries have the potential to overheating, melt or char. |
| 2011-01-12 | QIAGEN Gaithersburg, Inc. | The software component of a diagnostic medical device may be defective and could cause incorrect patient values. |
| 2009-03-12 | BioTek Instruments, Inc. | Software design allowed false negatives to be read when wells are dark. |
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Get your free API keyRead the docsData 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.