HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

FDA Device Recall #Z-1855-2025 — Class II — April 24, 2025

Recall Summary

Recall Number Z-1855-2025
Classification Class II — Moderate risk
Date Initiated April 24, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mckesson Medical-Surgical Inc. Corporate Office
Location Richmond, VA
Product Type Devices
Quantity 1 unit

Product Description

HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

Reason for Recall

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Distribution Pattern

US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.

Lot / Code Information

Catalog No. 180.013.002; GTIN: 8718734960935; Order No. 46096008.

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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.