Siemens Healthcare Diagnostics, Inc. 2022-05-11 Health serious FDA
Health · FDA · Recall #FDA-Z-1024-2022
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative… Recall
Issued May 11, 2022 · Siemens Healthcare Diagnostics, Inc.
In May 2022, Siemens Healthcare Diagnostics, Inc. recalled the ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
What you should do
- 1 Stop using ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Siemens Healthcare Diagnostics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Siemens Healthcare Diagnostics, Inc.
- Category
- Health
- Recall date
- May 11, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, E
- Recall number
- FDA-Z-1024-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Siemens Healthcare Diagnostics, Inc. has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.