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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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.
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