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Open, Classified

Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots

FDA Recall Z-1020-2022 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeCHP
Date Initiated2022-03-03
Product Quantity2,044 units

Reason for Recall

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

Firm Action

Siemens issued an Urgent Medical Device Correction AIMC 22-03.A.US and Urgent Field Safety Notice AIMC 22-03.A.OUS on 3/3/22. Letter states reason, health risk and action to take: Customers must discontinue use of plasma specimens for testing with the Atellica IM and ADVIA Centaur eE2 assays until further notice. Customers may continue to use the Atellica IM eE2 and ADVIA Centaur eE2 assays with serum specimens. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Questions: contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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