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Phadia Ab recalls Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number
Recalled April 11, 2018 · FDA recall Z-1276-2018 · Phadia Ab
Hazard
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU). · FDA Class II
Units
2307
Sold at
US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
Description
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
Product
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
Manufacturer(s)
Phadia Ab
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →