CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report
Accu-Chek Performa II Meter recalled by Roche Diabetes Care
Roche Diabetes Care is recalling Accu-Chek Performa II Meter, distributed nationwide in the US. The recall was initiated on 12 Jun 2017 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-2766-2019
- FDA event ID
- 83574
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2017
- FDA classified
- 30 Sep 2019
- Reported
- 9 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 12 Jun 2017 | Recall initiated by company | |
| 30 Sep 2019 | Classified by FDA | +840 days |
| 9 Oct 2019 | 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
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Which lots are affected?
Serial numbers less than xxx25525056 Updated serial numbers on 10/12/2019: Performa II: Between XXX20000000 and XXX25525056 Updated 10/18/2019: Performa II: from XXX20000000 to XXX25525056
Where was it sold?
Worldwide distribution - US Nationwide distribution.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83574This product is part of a recall event; the main page for the event is Accu-Chek Aviva II Meter recalled by Roche Diabetes Care.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Accu-Chek Aviva II Meter recalled by Roche Diabetes Care | Roche Diabetes Care | Device Malfunction | Nationwide |
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 | Other | 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 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |