Phadia Prime software — Class II medical device recall Z-1276-2018
Terminated recall by Phadia Ab, reported 2018-04-11, distributed in CA, GA, IN, MA, ME, MS, NC, NJ…. We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in
| Recall number | Z-1276-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia Ab, Uppsala, N/A, Sweden |
| Recall initiated | 2017-11-20 |
| Classified | 2018-03-30 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-03-06 |
| Distributed | CA, GA, IN, MA, ME, MS, NC, NJ, OR, TN, TX, UT, VA |
| Quantity | 2,307 |
| Reason classes | potency |
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.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1276-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.