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Glucose Dehydrogenase, Glucose

FDA product code LFR · Class 2 · Clinical Chemistry

414
Registered devices
74,205
Adverse events
51
Recalls
73
510(k) clearances

Devices with this code

TRUE METRIX — TRIVIDIA HEALTH, INC.CONTOUR® NEXT LINK — ASCENSIA DIABETES CARE US INC.Embrace EVO Strips, 50ct Vial - RETAIL — OMNIS HEALTHOneTouch Verio — LifeScan Europe GmbHCONTOUR®NEXT and MICROLET® — ASCENSIA DIABETES CARE US INC.Embrace TALK 50 ct. test strip — OMNIS HEALTH, LLCTRUE METRIX — TRIVIDIA HEALTH, INC.Accu-Chek Compact Plus — Roche Diabetes Care GmbHCONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.Oh’Care Lite Blood Glucose Test strips — OSANG HEALTHCARE Co., Ltd.Rosie — Southern Life Systems, Inc.FreeStyle InsuLinx — ABBOTT DIABETES CARE INCTRUE METRIX — TRIVIDIA HEALTH, INC.TRUE METRIX AIR — TRIVIDIA HEALTH, INC.EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) — OMNIS HEALTHiHealth — IHEALTH LAB INC.TRUE METRIX — TRIVIDIA HEALTH, INC.TRUE FOCUS — TRIVIDIA HEALTH, INC.TRUE METRIX — TRIVIDIA HEALTH, INC.Embrace EVO Mini Meter, all-in-one kit, RETAIL — OMNIS HEALTHDIABIMETRICS Blood Glucose Test Strips (50PCS) — Health For Mankind CompanyGHT Test Strip — GENESIS HEALTH TECHNOLOGIES, LLCEmbrace Control Solution Low — OMNIS HEALTH

Recent recalls

DateFirmReason
2021-07-28Roche 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
2021-07-28Roche 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
2018-05-07Roche 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 prio
2018-05-07Roche 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 prio
2018-05-07Roche 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 bloo
2016-02-11Roche 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
2012-02-21Lifescan IncAn 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
2011-08-12Bayer Healthcare, LLCAll 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
2009-05-13Roche Diagnostics Corp.The lancet cap may be missing, which could result in an unintended lancet stick to the user.
2009-05-13Roche Diagnostics Corp.The lancet cap may be missing, which could result in an unintended lancet stick to the user.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.