| Class 2 Device Recall Siemens ADVIA Centaur Enhanced Estradiol (eE2) | |
Date Initiated by Firm | March 03, 2022 |
Create Date | April 29, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1023-2022 |
Recall Event ID |
89953 |
Product Classification |
Radioimmunoassay, estradiol - Product Code CHP
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Product | ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots |
Code Information |
All lot numbers
UDI:
(01)00630414573342(10)08930076(17)20220115
(01)00630414573342(10)10982085(17)20221108
(01)00630414573342(10)19929072(17)20210819
(01)00630414573342(10)20298079(17)20220304
(01)00630414573342(10)48171081(17)20220304
(01)00630414573342(10)53554081(17)20220521
(01)00630414573342(10)70551083(17)20220805
(01)00630414573342(10)76055076(17)20220115
|
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 | 2,315 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.
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Total Product Life Cycle | TPLC Device Report |
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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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