G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer...
FDA Device Recall #Z-2066-2015 — Class III — February 10, 2015
Recall Summary
| Recall Number | Z-2066-2015 |
| Classification | Class III — Low risk |
| Date Initiated | February 10, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tosoh Bioscience, Inc. |
| Location | South San Francisco, CA |
| Product Type | Devices |
| Quantity | 9 boxes/5 pouches |
Product Description
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
Reason for Recall
The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
Distribution Pattern
Us Nationwide Distribution in the state ID including PR.
Lot / Code Information
Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
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| Z-2168-2017 | Class III | AIA-PACK TPOAb CONTROL SET | Feb 8, 2017 |
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| Z-1225-2017 | Class II | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c t... | Nov 7, 2016 |
| Z-2282-2016 | Class III | Instructions for Use (IFU) for Progesterone 3 C... | Jun 7, 2016 |
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.