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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85346

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

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Event summary

Timeline bucket
October 10, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Hologic, 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

Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

Z-2163-2020
Recall number
Z-2163-2020
Initiated
October 10, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Hologic, Inc
Quantity
47 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.

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

Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.

Code information

Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473

Distribution pattern

US: AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI OUS: AU, CA

Field note

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