Exact FDA event identifier

Event 91892

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

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Event summary

Timeline bucket: March 08, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: BioFire Diagnostics, LLC

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 Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Z-1392-2023

Recall number: Z-1392-2023
Initiated: March 08, 2023
Classification: Class II
Status: Ongoing
Recalling firm: BioFire Diagnostics, LLC
Quantity: 900 pouches (30 kits)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

Code information

Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

Distribution pattern

US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.