Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Produc...
FDA Device Recall #Z-2186-2018 — Class II — May 7, 2018
Recall Summary
| Recall Number | Z-2186-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 7, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diabetes Care, Inc. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 295,248 |
Product Description
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 Product Usage: The Accu-Chek Performa test strips are for use with the Accu-Chek Performa meter to quantitatively measure glucose (sugar) in venous whole blood or fresh capillary whole blood samples from the fingertips.
Reason for Recall
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
Distribution Pattern
Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Honduras Hong Kong (SAR China) Hungary India Indonesia Israel Italy Jamaica Japan Jordan Ireland Kenya Korea Kuwait Lebanon Lithuania Luxembourg Malaysia Malta Mexico Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Poland Russian Federation New Zealand Saudi Arabia Serbia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan (Republic of China), Thailand, United Arab Emirates, United Kingdom, Vietnam, Portugal"
Lot / Code Information
Lot 476605
Other Recalls from Roche Diabetes Care, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2174-2024 | Class II | Accu-Chek Guide (SC) Kit -Intended to quantitat... | May 13, 2024 |
| Z-1008-2022 | Class II | RocheDiabetes Care Platform Software version 2.... | Mar 9, 2022 |
| Z-2351-2021 | Class II | Accu-Chek Aviva Plus Test Strip, Blood Glucose ... | Jul 28, 2021 |
| Z-2354-2021 | Class II | Accu-Chek Inform II Test Strip, Whole Blood Glu... | Jul 28, 2021 |
| Z-2353-2021 | Class II | Accu-Chek SmartView Test Strip, Blood Glucose M... | Jul 28, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.