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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91863

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

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Event summary

Timeline bucket
February 17, 2023
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
AGILENT TECHNOLOGIES INC./US

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

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

Z-1358-2023
Recall number
Z-1358-2023
Initiated
February 17, 2023
Classification
Class III
Status
Ongoing
Quantity
560 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Distributed sample collection kit with an unapproved instruction for use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Distributed sample collection kit with an unapproved instruction for use.

Code information

Model/Part Number: 50032 UDI Code: N/A, single site PMA Lot Numbers: 23-0139 23-0140 23-0142 23-0143 23-0159

Distribution pattern

U.S. Nationwide distribution in the states of CA, GA, IN, NJ, and TX. O.U.S.: None