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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84887

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

Open FDA event record

Event summary

Timeline bucket
August 20, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Biofire Defense

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

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

Z-1448-2020
Recall number
Z-1448-2020
Initiated
August 20, 2019
Classification
Class III
Status
Terminated
Recalling firm
Biofire Defense
Quantity
92 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.

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

The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.

Code information

Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10

Distribution pattern

US: UT, MD, GA, CO, OH, TX, OUS: None