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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97419

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

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Event summary

Timeline bucket
July 17, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Quest International, 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

Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

Z-2552-2025
Recall number
Z-2552-2025
Initiated
July 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Quest International, Inc.
Quantity
376 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Measles IgM Test Kit lacks premarket approval or clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Measles IgM Test Kit lacks premarket approval or clearance.

Code information

UDI I# 00850487007104 - Lots affected: G00024; K04024; M11024; M12024; D01025; E04025,F04025

Distribution pattern

US Nationwide distribution in the states of Utah, Texas, and Arizona.