Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 8, 2020
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 Blo
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Diabetes Care, Inc. recalled Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAU… - a moderate-severity action.
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAU… was recalled by Roche Diabetes Care, Inc. in January 8, 2020. Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.. Check the official notice for the remedy. Verify recall #Z-0752-2020 with the FDA Devices before acting.
The recall
Roche Diabetes Care, Inc. issued this moderate-severity FDA Devices recall-Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System..
- Moderate
- severity level
- 452K units
- affected scope
- Class II
- classification
- January 8, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0752-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0752-2020) was formally reported on January 8, 2020, with the manufacturer initiating the action on September 30, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diabetes Care, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 452,392, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
452,392
Related Recalls
6
3 from same agency
Product description
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 for recall
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0752-2020 |
| Date reported | January 8, 2020 |
| Date initiated | September 30, 2019 |
| Recalling firm | Roche Diabetes Care, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 452,392 |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0752-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Roche Diabetes Care, Inc.. Units affected: 452,392.
Why was this product recalled? ▼
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2020. Severity: Moderate. Recall number: Z-0752-2020.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0752-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 8, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.