Roche Diabetes Care, Inc.
Complete recall history across all FDA and CPSC categories — 29 total recalls
Roche Diabetes Care, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (29)
FDA medical device enforcement actions by Roche Diabetes Care, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 13, 2024 | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... | The reason for recall is the meters may show an incorrect measurement unit (m... | Class II |
| Mar 9, 2022 | RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300... | Potential for patient data mismatch when using browser "back" button to navig... | Class II |
| Jul 28, 2021 | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number... | Test strip vials may open while inside sealed cartons during shipment. An ope... | Class II |
| Jul 28, 2021 | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model number... | Test strip vials may open while inside sealed cartons during shipment. An ope... | Class II |
| Jul 28, 2021 | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbe... | Test strip vials may open while inside sealed cartons during shipment. An ope... | Class II |
| Jul 28, 2021 | Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number ... | Test strip vials may open while inside sealed cartons during shipment. An ope... | Class II |
| Dec 11, 2019 | ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring Syste... | Inability to dose the test strips, may result in a temporary inability to get... | Class II |
| Dec 11, 2019 | Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitor... | Inability to dose the test strips, may result in a temporary inability to get... | Class II |
| Dec 11, 2019 | Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monit... | Inability to dose the test strips, may result in a temporary inability to get... | Class II |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RE... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring Sys... | Class II |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE ME... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring Sys... | Class II |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SA... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring Sys... | Class II |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RE... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring Sys... | Class II |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HC... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring Sys... | Class II |
| Sep 30, 2019 | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SA... | Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring Sys... | Class II |
| May 3, 2019 | Accu-Chek Connect Diabetes Management App | Users with Android OS 8.0 and above may be unable to transfer values obtained... | Class II |
| May 7, 2018 | Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. ... | The recalling firm has identified two lots of test strips that are out of spe... | Class II |
| May 7, 2018 | Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos... | The recalling firm identified four US lots of test strips out of specificatio... | Class II |
| May 7, 2018 | Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 0... | The recalling firm has identified two lots of test strips that are out of spe... | Class II |
| Jun 12, 2017 | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo... | Meters may contain a damaged C29 capacitor resulting in issues with power all... | Class II |
| Jun 12, 2017 | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G... | Meters may contain a damaged C29 capacitor resulting in issues with power all... | Class II |
| Jun 8, 2017 | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN ... | Certain iOS and Android App versions contain a program error (bug) in the Bol... | Class II |
| Jun 8, 2017 | Accu-Chek Connect diabetes management software app, Catalog number 0756246200... | Certain iOS and Android App versions contain a program error (bug) in the Bol... | Class II |
| Mar 14, 2017 | Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for... | A program error (bug) in the Bolus Advisor feature, which could result in inc... | Class II |
| Dec 20, 2016 | Accu-Chek Connect Diabetes Management App | iOS and Android: Under certain conditions the affected app versions may disre... | Class II |
| Sep 14, 2016 | Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on ... | Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 ... | Class II |
| Apr 22, 2015 | AccuChek Spirit insulin infusion pump. | Roche has become aware of an increase of mechanical errors experienced by cus... | Class II |
| Apr 22, 2015 | AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo S... | Roche has become aware of an increase of mechanical errors experienced by cus... | Class II |
| Oct 30, 2014 | ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to ... | Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect d... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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