Phadia Ab recalls Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number…

Recall date

November 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1276-2018

FDA classification

Class II

Brand / firm

Phadia Ab

Sold / distributed

US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.