Exact FDA event identifier

Event 90651

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

Open FDA event record

Event summary

Timeline bucket: July 19, 2022
Product types: Device
Classifications: Class II
Statuses: Completed
Recalling firm wording: Abbott Molecular, 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

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

The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

Z-1518-2022

Recall number: Z-1518-2022
Initiated: July 19, 2022
Classification: Class II
Status: Completed
Recalling firm: Abbott Molecular, Inc.
Quantity: 1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect optical calibration

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

Incorrect optical calibration

Code information

Serial Number 00654

Distribution pattern

There was only foreign distribution to Italy.