Siemens Healthcare Diagnostics, Inc. 2024-09-18 Health serious FDA
Health · FDA · Recall #FDA-Z-3065-2024
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number… Recall
Issued September 18, 2024 · Siemens Healthcare Diagnostics, Inc.
In September 2024, Siemens Healthcare Diagnostics, Inc. recalled the Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.
What you should do
- 1 Stop using Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number… 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
- Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Sloveni
- Recall number
- FDA-Z-3065-2024
- 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.