Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blo...
FDA Device Recall #Z-2174-2024 — Class II — May 13, 2024
Recall Summary
| Recall Number | Z-2174-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 13, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diabetes Care, Inc. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 48 units |
Product Description
Accu-Chek Guide (SC) Kit -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. Product REF Number: 08453071001
Reason for Recall
The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
Distribution Pattern
Nationwide and Worldwide
Lot / Code Information
GTIN: 00365702729100 Serial Numbers: US: 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052,92340120057, 92339744998. Canada:93040305146
Other Recalls from Roche Diabetes Care, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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 |
| Z-2352-2021 | Class II | Accu-Chek Performa Test Strip, Blood Glucose Mo... | 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.