Siemens Healthcare Diagnostics, Inc. 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-3100-2024
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of… Recall
Issued September 18, 2024 · Siemens Healthcare Diagnostics, Inc.
In September 2024, Siemens Healthcare Diagnostics, Inc. recalled the Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
What you should do
- 1 Stop using Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of… 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
- September 18, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution
- Recall number
- FDA-Z-3100-2024
- 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 737th Health recall we've logged in 2024.