Class II — Phadia Ab
| Recalling firm | PHADIA AB |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 2307 |
| Distribution | US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR |
| Initiated | 2017-11-20 |
| Classified | 2018-03-30 |
| Terminated | 2019-03-06 |
| Recall number | Z-1276-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Phadia Ab (Z-1276-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79438/
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