The Recall Desk
HighFDA (Devices)·Z-3065-2024·Announced 2024-09-18

Siemens Dimension Vista Bilirubin Reagent Cartridges Recalled Due to Underfilled Wells

Siemens Healthcare Diagnostics is recalling one lot of Dimension Vista Total Bilirubin Flex Reagent Cartridges due to underfilled wells during manufacturing. The defect may result in inaccurate test results for calibrators, quality control, and patient samples.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving potential diagnostic inaccuracy. No illnesses, injuries, or deaths have been reported. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling lot 23206BA of the Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge (Siemens Material Number 10445146). A total of 5,371 units were distributed: 4,394 in the United States and 977 internationally to Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, and Switzerland.

During manufacturing, a filling line issue resulted in underfilled wells in lot 23206BA. Specifically, wells 8 or 10 from the last three tests of the 160-test flex cartridge contained insufficient reagent. This manufacturing defect may cause test results to be inaccurate for calibrators, quality control measurements, and patient samples.

Healthcare facilities and clinical laboratories that received lot 23206BA should take appropriate action regarding any test results generated from this lot. The recall affects diagnostic testing capabilities for total bilirubin measurement.

The recalled product

Product
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
  • diagnostic-inaccuracy
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Siemens Material Number (SMN): 10445146
  • UDI-DI: 00842768015717
  • Lot Number: 23206BA

Distribution

Distributed nationwide across the United States.

Related recalls

Same category