Indianapolis, IN, United States
Roche Diabetes Care, Inc. recalls
9 recalls recorded since 2018, most recently on 13 May 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)2
Terminated or completed7
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 May 2024
- 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 approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
- Distribution
- Nationwide and Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2174-2024
- Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Numbe
Terminated Class II Medical devices
- Recall started
- 9 March 2022
- Terminated
- 22 January 2025
- Reason
- Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
- Distribution
- US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1008-2022
- RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Ongoing Class II Medical devices
- Recall started
- 28 July 2021
- 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 inappropriate therapy decisions and adverse health consequences.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2352-2021, Z-2351-2021, Z-2353-2021, Z-2354-2021
- Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
- Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
- Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
- Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Terminated Class II Medical devices
- Recall started
- 11 December 2019
- Terminated
- 8 July 2022
- 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
- Distribution
- Nationwide: Foreign: Austalia, India
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0997-2020, Z-0998-2020, Z-0999-2020
- Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
- Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
- ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
Terminated Class II Medical devices
- Recall started
- 30 September 2019
- Terminated
- 29 July 2020
- Reason
- Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
- Distribution
- US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0751-2020, Z-0752-2020, Z-0748-2020, Z-0747-2020, Z-0749-2020, Z-0750-2020
- Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fre
- Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh
- Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capi
- Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capi
- Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh c
- Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fre
Terminated Class II Medical devices
- Recall started
- 3 May 2019
- Terminated
- 30 October 2020
- Reason
- Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
- Distribution
- Nationwide and worldwide usage of the Connect App.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2753-2019
- Accu-Chek Connect Diabetes Management App
Terminated Class II Medical devices
- Recall started
- 7 May 2018
- Terminated
- 16 January 2020
- 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 inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
- Distribution
- Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Gha
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2186-2018, Z-2185-2018, Z-2187-2018
- Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucos
- Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviv
- Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glu
Terminated Class II Medical devices
- Recall started
- 12 June 2017
- Terminated
- 30 October 2020
- Reason
- Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2765-2019, Z-2766-2019
- Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples draw
- Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples d
Terminated Class II Medical devices
- Recall started
- 8 June 2017
- Terminated
- 27 July 2018
- 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 unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0625-2018
- Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.