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DPP Zika IgM Micro Reader

Chembio Diagnostic Systems Inc. · Model 70-1064-0 · UDI-DI 00607158000113

JJQ Prescription

510(k) clearances

355

Adverse events (1 deaths)

Recalls

Facilities

Description

The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results of the DPP Zika IgM test cartridge, through the application of an RFID tag applied to one side of the reader, which carries the DPP Zika test configuration. Once configured, the reader measures the intensity of the control and analyte lines on the test device, and shows the test results on the LCD display. The DPP Micro Reader minimizes human errors due to subjective visual interpretation; therefore, the operator cannot visually interpret the results of DPP Assay Devices made to be read with a DPP Micro Reader; they must be read exclusively with the DPP Micro Reader.

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.