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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92271

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

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Event summary

Timeline bucket
April 24, 2023
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Abbott Ireland Limited

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 Anti-TPO Reagent Kit, List Number 09P3521

Z-1696-2023
Recall number
Z-1696-2023
Initiated
April 24, 2023
Classification
Class III
Status
Ongoing
Recalling firm
Abbott Ireland Limited
Quantity
110 kits

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing fill volume error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

Code information

UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024

Distribution pattern

US Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.