Siemens Healthcare Diagnostics, Inc. 2022-06-15 Health serious FDA
Health · FDA · Recall #FDA-Z-1252-2022
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro… Recall
Issued June 15, 2022 · Siemens Healthcare Diagnostics, Inc.
In June 2022, Siemens Healthcare Diagnostics, Inc. recalled the Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
What you should do
- 1 Stop using Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro… 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
- June 15, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China,
- Recall number
- FDA-Z-1252-2022
- 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.