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iPeak® reader 4,3" Lateral Flow Reader

IUL SA · Model 100033000US1 · UDI-DI 08437022431482

JJQ Prescription

510(k) clearances

355

Adverse events (1 deaths)

Recalls

Facilities

Description

The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.x) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of photometric immunochromatographic test defined and marketed by IUL’ partners. The iPeak® reader 4,3” is intended to be used only in combination with lateral flow (LF) tests indicated for use with the iPeak® reader 4,3”, and only for applications that are described in the respective handbooks of our reader associates.

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.