Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determina...
FDA Device Recall #Z-2041-2016 — Class II — May 2, 2016
Recall Summary
| Recall Number | Z-2041-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 2, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc |
| Location | East Walpole, MA |
| Product Type | Devices |
| Quantity | SMN 10317708 = 16434 kits and SMN 10317709 = 16033 kits |
Product Description
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems Cat No. 02789602/SMN 1031 7708 (100 test) Cat No. 02790309/SMN 10317709 (500 test)
Reason for Recall
Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
Distribution Pattern
Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.
Lot / Code Information
All in date lots
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.