—#192972

Product

Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

FDA product code: CHP — Radioimmunoassay, Estradiol
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All lot numbers UDI: 01)00630414598864(10)10054080(17)20220303 (01)00630414598864(10)10979086(17)20221107 (01)00630414598864(10)53378082(17)20220521 (01)00630414598864(10)70532084(17)20220804

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

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.

Timeline

Recall initiated: 2022-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.