Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phadia Prime software Recalled by Phadia Ab Due to We want to inform all Phadia 250 system...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Phadia Ab directly.
Affected 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.
Quantity: 2307
Why Was This 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).
Where Was This Sold?
This product was distributed to 13 states: CA, GA, IN, ME, MA, MS, NJ, NC, OR, TN, TX, UT, VA
About Phadia Ab
Phadia Ab has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report