Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
FDA Device Recall #Z-1225-2017 — Class II — November 7, 2016
Recall Summary
| Recall Number | Z-1225-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 7, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tosoh Bioscience, Inc. |
| Location | South San Francisco, CA |
| Product Type | Devices |
| Quantity | 682 analyzers |
Product Description
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Reason for Recall
The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
Distribution Pattern
Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,
Lot / Code Information
All active analyzers
Other Recalls from Tosoh Bioscience, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2168-2017 | Class III | AIA-PACK TPOAb CONTROL SET | Feb 8, 2017 |
| Z-2169-2017 | Class III | AIA-PACK TgAb CONTROL SET | Feb 8, 2017 |
| Z-2282-2016 | Class III | Instructions for Use (IFU) for Progesterone 3 C... | Jun 7, 2016 |
| Z-2066-2015 | Class III | G7 Variant Elution Buffer HiS no. 1 (M) compone... | Feb 10, 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.