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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83341

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

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Event summary

Timeline bucket
November 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Ireland Diagnostics Division

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

Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.

Z-2208-2019
Recall number
Z-2208-2019
Initiated
November 21, 2018
Classification
Class II
Status
Terminated
Quantity
216 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

Code information

UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00

Distribution pattern

US Distribution to states of: AR, FL, GA, MD, OK and VA.