FDA (Devices) recall action 76915
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens is recalling Dimension Troponin 1 reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.
Siemens Healthcare Diagnostics is recalling Dimension Vista Ferritin reagent cartridges because the instructions for use contain incorrect units and levels for biotin interference.
Siemens Healthcare Diagnostics is recalling Dimension Vista Estradiol reagent cartridges because the instructions for use contain incorrect biotin interference units.
Siemens Healthcare Diagnostics is recalling Dimension Vista Digoxin reagent cartridges because the instructions for use contain incorrect units and levels for biotin interference.
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.
Siemens Healthcare Diagnostics is recalling Dimension Vista Prolactin reagent cartridges because the instructions for use contain incorrect biotin interference data.