Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The devi...
FDA Device Recall #Z-1812-2018 — Class II — March 5, 2018
Recall Summary
| Recall Number | Z-1812-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 5, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tosoh Bioscience Inc |
| Location | Grove City, OH |
| Product Type | Devices |
| Quantity | 2258 |
Product Description
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Reason for Recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Distribution Pattern
USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Lot / Code Information
All lots.
Other Recalls from Tosoh Bioscience Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2968-2020 | Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Veri... | Aug 7, 2020 |
| Z-2967-2020 | Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-I... | Aug 7, 2020 |
| Z-2423-2020 | Class II | AIA-900 Analyzer, Part no. 022930, UDI 04560189... | May 22, 2020 |
| Z-1420-2020 | Class II | AIA-360 Automated Immunoassay Analyzer, Product... | Jan 10, 2020 |
| Z-0675-2019 | Class II | ST AIA-PACK Homocysteine (HCY) is designed for ... | Nov 30, 2018 |
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.