Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

FDA Device Recall #Z-2203-2021 — Class III — July 12, 2021

Recall Summary

Recall Number Z-2203-2021
Classification Class III — Low risk
Date Initiated July 12, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stanbio Laboratory, LP
Location Boerne, TX
Product Type Devices
Quantity 93 units

Product Description

Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

Reason for Recall

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

Lot / Code Information

Catalog Number/Product Description: CHB2440180/Cardinal Health ¿-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX Device Identifier: 10885380173141 Lot Numbers: 164986;

Other Recalls from Stanbio Laboratory, LP

Recall # Classification Product Date
Z-0490-2024 Class II STAT-Site M BHB Test Strips, used with STAT-SIT... Oct 2, 2023
Z-0905-2022 Class II Separation Technology Creamatocrit Plus, Catalo... Mar 16, 2022
Z-2200-2021 Class III Beta-Hydroxybutyrate Reagent A - Enzyme (unlabe... Jul 12, 2021
Z-2201-2021 Class III Synchron CX/DX/LX Beta-Hydroxybutyrate . in vi... Jul 12, 2021
Z-2202-2021 Class III Cardinal Health Beta-Hydroxybutyrate . in vitr... Jul 12, 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.