FDA Medical Device Recalls (openFDA)
Phadia Ab: 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.
- Recall number
- Z-1276-2018
- Recalling firm
- Phadia Ab
- 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.
- Status
- Terminated
- Initiated
- 2017-11-20
- Posted
- not on file
- Terminated
- 2019-03-06
- 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).
- Root cause
- Software design
- Action
- An urgent recall notification was issued to customers in November of 2017, and informs 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). For further questions, please call (269) 492-1940.
- Quantity
- 2307
- Distribution
- US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
- Lot, serial or model codes
- Phadia Prime software 12-4101-00 Phadia 250 12-3900-01 Listed software: EliA dsDNA Well 14-5500-01 EliA U1RNP Well 14-5501-01 EliA Sm Well 14-5502-01 EliA Ro Well 14-5503-01 EliA La Well 14-5504-01 EliA CENP Well 14-5505-01 EliA Scl-70 Well 14-5506-01 EliA Jo-1 Well 14-5507-01 EliA Symphony Well 14-5508-01 EliA RNP70 Well 14-5511-01 EliA GBM Well 14-5514-01 EliA CCP Well 14-5515-01 EliA Celikey IgA Well 14-5517-01 EliA Celikey IgG Well 14-5518-01 EliA Gliadin IgA Well 14-5519-01 EliA Gliadin IgG Well 14-5520-01 EliA Cardiolipin IgA Well 14-5528-01 EliA Cardiolipin IgG Well 14-5529-01 EliA Cardiolipin IgM Well 14-5530-01 EliA B2-Glycoprotein I IgA Well 14-5531-01 EliA B2-Glycoprotein I IgG Well 14-5532-01 EliA B2-Glycoprotein I IgM Well 14-5533-01 EliA PR3S Well 14-5536-01 EliA MPOS Well 14-5537-01 EliA GliadinDP IgA Well 14-5538-01 EliA GliadinDP IgG Well 14-5539-01 EliA RF IgM Well 14-5600-01 EliA RF IgA Well 14-5601-01 EliA SmDP Well 14-5624-01 EliA Scl-70S Well 14-5637-01 EliA anti-TPO Well 14-5641-01 EliA anti-TG Well 14-5642-01 EliA M2 Well 14-5649-01
- 510(k) numbers
- ["K151029"]
- PMA numbers
- not on file
- Product code
- DHB
- Firm FEI
- 3002807876
- Firm city
- Uppsala
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28