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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83472

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

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Event summary

Timeline bucket
July 16, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Luminex Molecular Diagnostics

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

xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

Z-0161-2020
Recall number
Z-0161-2020
Initiated
July 16, 2019
Classification
Class II
Status
Ongoing
Quantity
56 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.

Code information

Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132

Distribution pattern

US distribution to CA, CT, MA, and PA OUS: None