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Excel® Chemistry Analyzer (Spanish)

STANBIO LABORATORY, L.P. · Model G7700S-001 · UDI-DI 00657498000397

JJQ Prescription

510(k) clearances

355

Adverse events (1 deaths)

Recalls

Facilities

Description

This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application.

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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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.