Roche Diabetes Care recalls
Roche Diabetes Care appears in 29 official U.S. recall notices indexed by RecallRadar, most recently on 2024-07-03.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 29 |
|---|---|
| Published | 2015-04-08 to 2024-07-03 |
| By agency | FDA Device (29) |
| By classification | Class II (29) |
| By status | terminated (24), ongoing (5) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, VA, WA, WI, WV |
Recalls
- Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
FDA Device · Class II · 2024-07-03 · Roche Diabetes Care
Reason: The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approx… - RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
FDA Device · Class II · 2022-05-04 · Roche Diabetes Care
Reason: Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software. - Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
Reason: 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 results, potentially leading to inappr… - Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
Reason: 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 results, potentially leading to inappr… - Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
Reason: 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 results, potentially leading to inappr… - Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 069083…
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
Reason: 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 results, potentially leading to inappr… - ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
FDA Device · Class II · 2020-02-12 · Roche Diabetes Care
Reason: Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions - Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
FDA Device · Class II · 2020-02-12 · Roche Diabetes Care
Reason: Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions - Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
FDA Device · Class II · 2020-02-12 · Roche Diabetes Care
Reason: Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions - Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Bloo…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. - Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Gluco…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. - Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Gluco…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. - Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Bloo…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. - Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. - Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Gl…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. - Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the qua…
FDA Device · Class II · 2019-10-09 · Roche Diabetes Care
Reason: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). - Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quanti…
FDA Device · Class II · 2019-10-09 · Roche Diabetes Care
Reason: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). - Accu-Chek Connect Diabetes Management App
FDA Device · Class II · 2019-10-02 · Roche Diabetes Care
Reason: Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. - Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips a…
FDA Device · Class II · 2018-06-20 · Roche Diabetes Care
Reason: 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 blood sample; strips not detected once inse… - Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips…
FDA Device · Class II · 2018-06-20 · Roche Diabetes Care
Reason: 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 blood sample; strips not detected once inse… - Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Us…
FDA Device · Class II · 2018-06-20 · Roche Diabetes Care
Reason: 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 detected once inserted, or biased results, wh… - Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN numb…
FDA Device · Class II · 2018-02-21 · Roche Diabetes Care
Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpect… - Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / G…
FDA Device · Class II · 2017-12-13 · Roche Diabetes Care
Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown… - Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product avai…
FDA Device · Class II · 2017-05-10 · Roche Diabetes Care
Reason: A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery. - Accu-Chek Connect Diabetes Management App
FDA Device · Class II · 2017-02-01 · Roche Diabetes Care
Reason: iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and… - Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
FDA Device · Class II · 2016-11-23 · Roche Diabetes Care
Reason: Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the… - AccuChek Spirit insulin infusion pump
FDA Device · Class II · 2015-06-17 · Roche Diabetes Care
Reason: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and… - AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System
FDA Device · Class II · 2015-06-17 · Roche Diabetes Care
Reason: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and… - ACCU-CHEK Connect Diabetes Management App
FDA Device · Class II · 2015-04-08 · Roche Diabetes Care
Reason: Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situ…