Lower riskMedical device recall · FDA · Published July 30, 2024
Siemens Dimension Vista TBIL Reagent Cartridge Recall: Underfill Risk
Siemens recalls Dimension Vista TBIL Flex Reagent Cartridges with lot 23206BA due to potential underfilling during manufacturing, which may affect calibrator and patient results.
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.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.500 Gbc Dr · Newark, DE 19702-2466
“Siemens Dimension Vista TBIL Reagent Cartridge Recall: Underfill Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54381-siemens-dimension-vista-tbil-reagent-cartridge-recall-underfill-risk. Based on FDA recall #Z-3065-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3065-2024%22&limit=1).
The FDA announced on July 30, 2024, that Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridges due to potential underfilling during manufacturing. This defect could impact calibrator, quality control, and patient results.
How to tell if you have it
Brand: Siemens Healthcare
Product: Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge
Siemens Material Number (SMN): 10445146
UDI-DI: 00842768015717
Lot Number: 23206BA
The hazard
During manufacturing, an issue with the filling line caused some wells in lot 23206BA to underfill. This defect may have impacted calibrator, quality control (QC), and patient results.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls include the Siemens Atellica CH RCRP Test recall (Aug. 17, 2026) and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Similar product recalls include the Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026) and the Henry Schein Structur 2 SC Resin Cartridge Refills recall (July 9, 2026).
How to tell if you have this one
Check for lot number 23206BA on the Siemens Dimension Vista TBIL Flex Reagent Cartridge. The product has Siemens Material Number (SMN) 10445146 and UDI-DI 00842768015717.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for lot number 23206BA on the reagent cartridge packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3065-2024 (July 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3065-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.