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CONTOUR® NEXT EZ

ASCENSIA DIABETES CARE US INC. · Model 9628 · UDI-DI 00301939628014

LFR NBW Prescription

510(k) clearances

74,205

Adverse events (33 deaths)

Recalls

Facilities

Description

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. This kit contains the following items: CONTOUR® Next EZ Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case.

Recalls

Date	Firm	Reason
2021-07-28	Roche Diabetes Care, Inc.	Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate
2021-07-28	Roche Diabetes Care, Inc.	Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate
2018-05-07	Roche Diabetes Care, Inc.	The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detect
2018-05-07	Roche Diabetes Care, Inc.	The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a bloo
2018-05-07	Roche Diabetes Care, Inc.	The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a bloo
2016-02-11	Roche Diagnostics Operations, Inc.	Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The
2012-02-21	Lifescan Inc	An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a mul
2011-08-12	Bayer Healthcare, LLC	All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a
2009-05-13	Roche Diagnostics Corp.	The lancet cap may be missing, which could result in an unintended lancet stick to the user.
2009-05-13	Roche Diagnostics Corp.	The lancet cap may be missing, which could result in an unintended lancet stick to the user.

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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.