FDA Device recall Z-0752-2020
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
- terminated
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood… by Roche Diabetes Care, citing potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0752-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-30 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diabetes Care |
| Distribution | US |
Product
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 capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
Reason
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Identifiers
| code_info | Model Number : 08313202001 Device Identifier: 00365702702349 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Roche Diabetes Care
- 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 - RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
FDA Device · Class II · 2022-05-04 · Roche Diabetes Care - Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care - Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
All Roche Diabetes Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.