CLASS II Device recall · Reported 8 Jan 2020 · FDA Enforcement Report
Blood Glucose Monitoring System recalled by Roche Diabetes Care
Roche Diabetes Care is recalling Blood Glucose Monitoring System, distributed nationwide in the US. The recall was initiated on 30 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0750-2020
- FDA event ID
- 84119
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Sep 2019
- FDA classified
- 30 Dec 2019
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 30 Sep 2019 | Recall initiated by company | |
| 30 Dec 2019 | Classified by FDA | +91 days |
| 8 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Product as listed by the FDA
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 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.
Where it was distributed
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.
Questions about this recall
Is Blood Glucose Monitoring System recalled?
Yes. Roche Diabetes Care recalled Blood Glucose Monitoring System on 30 Sep 2019. The recall is Class II and its status is Terminated. Recall number Z-0750-2020.
Why was it recalled?
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Which lots are affected?
Model Number : 08453071001 Device Identifier: 00365702729100 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roche Diabetes Care
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accu-Chek Guide (SC) Kit -Intended to quantitatively recalled | Roche Diabetes Care | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | RocheDiabetes Care Platform recalled | Roche Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |