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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Atellica IM Enhanced Estradiol (eE2)

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  Class 2 Device Recall Siemens Atellica IM Enhanced Estradiol (eE2) see related information
Date Initiated by Firm March 03, 2022
Create Date April 29, 2022
Recall Status1 Open3, Classified
Recall Number Z-1020-2022
Recall Event ID 89953
Product Classification Radioimmunoassay, estradiol - Product Code CHP
Product Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Code Information All lot numbers UDI: (01)00630414598857(10)53376082(17)20220521 (01)00630414598857(10)53377082(17)20220521 (01)00630414598857(10)70533084(17)20220804
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact SAME
508-668-5000
Manufacturer Reason
for Recall		 Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
FDA Determined
Cause 2		 Under Investigation by 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
Quantity in Commerce 2,044 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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