Z-3065-2024Class II

Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146

Name: Z-3065-2024 Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-07-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-07-30 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146 on 2024-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3065-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-30
Posted: 2024-09-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On July 30, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Impact to Results: 1. Erroneously depressed or elevated total bilirubin patient results may have occurred, even if QC was within range. 2. A negative bias of >-98% (erroneous result <0.1 mg/dL [2 mol/L] at a true concentration of 4.0 mg/dL [69 mol/L]) and a positive bias of up to 3,950% (erroneous result 16.2 mg/dL [277 mol/L] at a true concentration of 0.4 mg/dL [7 mol/L]) was observed. Results of this test should always be interpreted in conjunction with the patient s medical history, clinical presentation and other findings. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Complete and return the Field Correction Effectiveness Check form attached within 30 days and indicate product replacement needs if retesting of patients is performed. 3. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution: The cause of the filling issue has been determined and resolved by Siemens Healthineers. Mitigation that will prevent this issue from occurring in the future has been put in place. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 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.
Product codes and lots: Siemens Material Number (SMN): 10445146; UDI-DI: 00842768015717; Lot Number: 23206BA;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3065-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3065-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-06

Product code CIG

K061719Class IIDimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/dbil Calibrator; Models K1167, Kc212Dade Behring, Inc. / cleared 2006-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)