Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Device Recall #Z-1233-2019 — Class II — December 7, 2018
Recall Summary
| Recall Number | Z-1233-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 7, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc |
| Location | East Walpole, MA |
| Product Type | Devices |
| Quantity | 10673 kits |
Product Description
Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
Reason for Recall
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
Distribution Pattern
Nationwide Foreign: Belgium¿¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿ BOGOTA QUARRY BAY, HONG KONG YANGON SANTIAGO DE CHILE MONTEVIDEO BUENOS AIRES LIMA JOINVILLE, SC, BRAZIL Selangor Darul Ehsan Dhaka Ha Noi City Gurgaon, Haryana Hanoi-Hoangmai ASUNCION SHANGHAI Seoul 120 SINGAPORE RIYADH 11411 TAIPEI R.O.C. QUITO HUNTINGWOOD, NEW SOUTH WALES ZAPOPAN Ho Chi Minh-District 3 Huaykwang, Bangkok RIYADH SAN JOSE CHIBA LAVAL HO CHI MINH CITY MANAGUA Gurgaon, Haryana
Lot / Code Information
Lot Number/Exp. Date: 68748302 12/13/2018 68749302 12/13/2018 83577304 1/12/2019 88637304 1/12/2019 5610306 2/11/2019 96436306 2/11/2019 19097308 3/14/2019 31866310 4/27/2019 45386310 4/27/2019 55627312 5/27/2019 69208316 6/29/2019 73000316 6/29/2019
Other Recalls from Siemens Healthcare Diagnostics, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0124-2022 | Class II | Atellica IM 1300 Analyzer, SMN 11066001 | Sep 28, 2021 |
| Z-0125-2022 | Class II | Atellica IM 1600 Analyzer, SMN 11066000 | Sep 28, 2021 |
| Z-0196-2022 | Class II | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Tes... | Sep 22, 2021 |
| Z-0195-2022 | Class II | Atellica IM SARS-CoV-2 Antigen Assay (100 Test ... | Sep 22, 2021 |
| Z-2425-2021 | Class II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit- i... | Jul 6, 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.