Siemens Healthcare Diagnostics, Inc. has recalled 5,371 units of Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridges because an issue on the manufacturing filling line caused some test wells to be underfilled. This defect specifically affects the last three tests of the 160-test cartridge (wells 8 or 10) in lot 23206BA. Using these underfilled wells can lead to incorrect calibrator, quality control, and patient test results, which may impact medical decision-making. These cartridges were distributed nationwide in the United States and internationally.
Underfilled reagent wells can cause the diagnostic platform to produce inaccurate bilirubin measurements. Incorrect patient results could lead to improper medical diagnosis or delayed treatment for conditions related to liver function or blood disorders.
Manufacturer initiated recall notification via letter.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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