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Roche Diabetes Care, Inc.

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary wh recall (Z-2174-2024)Roche Diabetes Care, Inc.2024-06-21
Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL recall (Z-0747-2020)Roche Diabetes Care, Inc.2019-12-30
Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL recall (Z-0748-2020)Roche Diabetes Care, Inc.2019-12-30
Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL recall (Z-0749-2020)Roche Diabetes Care, Inc.2019-12-30
Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN M recall (Z-0750-2020)Roche Diabetes Care, Inc.2019-12-30
Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN M recall (Z-0751-2020)Roche Diabetes Care, Inc.2019-12-30
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNC recall (Z-0752-2020)Roche Diabetes Care, Inc.2019-12-30
Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monito recall (Z-2765-2019)Roche Diabetes Care, Inc.2019-09-30
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Mon recall (Z-2766-2019)Roche Diabetes Care, Inc.2019-09-30
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001 recall (Z-2185-2018)Roche Diabetes Care, Inc.2018-05-09
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Pr recall (Z-2186-2018)Roche Diabetes Care, Inc.2018-05-09
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 P recall (Z-2187-2018)Roche Diabetes Care, Inc.2018-05-09
Accu-Chek Connect Diabetes Management App recall (Z-1099-2017)Roche Diabetes Care, Inc.2017-01-26
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 recall (Z-0586-2017)Roche Diabetes Care, Inc.2016-11-16
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System. recall (Z-1733-2015)Roche Diabetes Care, Inc.2015-06-09
AccuChek Spirit insulin infusion pump. recall (Z-1734-2015)Roche Diabetes Care, Inc.2015-06-09
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data fo recall (Z-1369-2015)Roche Diabetes Care, Inc.2015-04-02

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Every clearance here is in the API, with alerts when new ones post.