FDA-Device2018-04-11Class II
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.
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).
Sold states
US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
Affected count
2307
Manufactured in
Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, Sweden
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1276-2018Don't want to check this manually?
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