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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94910

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

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Event summary

Timeline bucket
June 17, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Abbott Diagnostics Technologies AS

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

Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.

Z-2736-2024
Recall number
Z-2736-2024
Initiated
June 17, 2024
Classification
Class II
Status
Ongoing
Quantity
5 analyzers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

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Inspect official wording and provenance

Reason for recall

Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.

Code information

Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.

Distribution pattern

US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.