Dimension Vista¿ Total Bilirubin recall
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Why was Dimension Vista¿ Total Bilirubin recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA;
- Product
- Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 5,371 units (4,394 US, 977 OUS)
- Distribution
- Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.
- Recall date
- September 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)