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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79438

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 20, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Phadia Ab

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1276-2018
Recall number
Z-1276-2018
Initiated
November 20, 2017
Classification
Class II
Status
Terminated
Recalling firm
Phadia Ab
Quantity
2307

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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

Distribution pattern

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