Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN...
FDA Device Recall #Z-1078-2016 — Class II — February 4, 2016
Recall Summary
| Recall Number | Z-1078-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 4, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc |
| Location | East Walpole, MA |
| Product Type | Devices |
| Quantity | 6455 (6 pack) |
Product Description
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Reason for Recall
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Distribution Pattern
Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA
Lot / Code Information
Lot code/ Exp.Date: 86344A42 May 9, 2016; 55437A42 May 9, 2016; 54801A42 May 9, 2016; 53651A42 May 9, 2016; 53625A42 May 9, 2016; 15610A43 November 27, 2016; 18375A43 November 27, 2016; 24990A43 November 27, 2016; 38988A43 November 27, 2016
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.