Exact FDA event identifier

Event 79444

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 18, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Phadia US Inc

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

2 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 2

ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

Z-1312-2018

Recall number: Z-1312-2018
Initiated: December 18, 2017
Classification: Class II
Status: Terminated
Recalling firm: Phadia US Inc
Quantity: 950 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

Code information

Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY

Distribution pattern

Nationwide Distribution

device · product 2 of 2

ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

Z-1313-2018

Recall number: Z-1313-2018
Initiated: December 18, 2017
Classification: Class II
Status: Terminated
Recalling firm: Phadia US Inc
Quantity: 950 total