PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported October 9, 2019

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 drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

Recall #
Z-2766-2019
Affected scope
N/A
Initiated
June 12, 2017
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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Roche Diabetes Care, Inc. recalled Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Mo… - a moderate-severity action.

Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Mo… was recalled by Roche Diabetes Care, Inc. in October 9, 2019. Reason: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or m…. Check the official notice for the remedy. Verify recall #Z-2766-2019 with the FDA Devices before acting.

The recall

Roche Diabetes Care, Inc. issued this moderate-severity FDA Devices recall-Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or m….

Moderate
severity level
Class II
classification
October 9, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2766-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2766-2019) was formally reported on October 9, 2019, with the manufacturer initiating the action on June 12, 2017. 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 N/A.

The documented reason for this recall is: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution.. 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

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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.

Severity

Moderate

Affected scope

N/A

Related Recalls

6

3 from same agency

Product description

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 drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Reason for recall

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2766-2019
Date reported October 9, 2019
Date initiated June 12, 2017
Recalling firm Roche Diabetes Care, Inc.
Firm location Indianapolis, IN
Affected scope N/A
Distribution Worldwide distribution - US Nationwide distribution.

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-2766-2019) 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?
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 drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.. Recalled by Roche Diabetes Care, Inc.. Units affected: N/A.
Why was this product recalled?
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Which agency issued this recall?
This recall was issued by the FDA Devices on October 9, 2019. Severity: Moderate. Recall number: Z-2766-2019.
Where was the recalled product distributed?
Distribution: Worldwide distribution - US Nationwide distribution..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2766-2019) 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 October 9, 2019. 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.