arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. ...
FDA Device Recall #Z-0630-2016 — Class I — December 18, 2015
Recall Summary
| Recall Number | Z-0630-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | December 18, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arkray Factory USA, Inc. |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 88 boxes (25 foil packaged test strips per box) |
Product Description
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
Reason for Recall
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
Distribution Pattern
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Lot / Code Information
Lot Number EA4M78
Other Recalls from Arkray Factory USA, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1850-2019 | Class II | AUTION HYBRID AU-4050 | May 3, 2019 |
| Z-0631-2016 | Class I | arkray SPOTCHEM II Basic Panel - 1 Reagent test... | Dec 18, 2015 |
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.