Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative det...

FDA Device Recall #Z-1022-2022 — Class II — March 3, 2022

Recall Summary

Recall Number Z-1022-2022
Classification Class II — Moderate risk
Date Initiated March 3, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics, Inc.
Location East Walpole, MA
Product Type Devices
Quantity 230 units

Product Description

Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots

Reason for Recall

Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

Lot / Code Information

All lot numbers UDI: (01)00630414293639(10)01380084(17)20220804 (01)00630414293639(10)20299080(17)20220303

Other Recalls from Siemens Healthcare Diagnostics, Inc.

Recall # Classification Product Date
Z-1484-2026 Class II Atellica CH Urine Albumin (UAlb). Material Numb... Jan 20, 2026
Z-0491-2026 Class II IMMULITE 2000 Oak Mix Specific Allergen; Sieme... Oct 6, 2025
Z-0492-2026 Class II 3gAllergy Specific IgE Universal Kit; Kit Comp... Oct 6, 2025
Z-0493-2026 Class II Food Panel 3 Specific Allergen; Siemens Materi... Oct 6, 2025
Z-0366-2026 Class II Assay: IMMULITE 2000 Intact PTH; Test Code: iP... Sep 22, 2025

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.