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Diagnostic Automation

Diagnostic Automation, Inc. · Model DAR800TS · UDI-DI 00894175000480

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

Description

DA800TS Microplate Reader is an affordable, high-quality microplate reader for assays in 6- to 96-well formats. The color touchscreen provides a visual user interface, making programming simple. The onboard software includes “quick read” and custom protocols, with data viewed immediately after measure, followed by export to USB or to the compact printer.

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.