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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92397

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 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

2 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 2

BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

Z-2439-2023
Recall number
Z-2439-2023
Initiated
May 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
BioFire Diagnostics, LLC
Quantity
705 kits (30 pouches/kit)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to manufacturing issue, panels may result in false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to manufacturing issue, panels may result in false negative results.

Code information

Pouch Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23, Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23, Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23, Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23, Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23, Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23, Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23, Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23, Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23, Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23, Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23, Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23, Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23, Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23, Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23, Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23, Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23, Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23, Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23, Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23, Pouch Lot # 2N6222 Kit # 2168322 Exp. 22-Nov-23, Pouch Lot # 2N6R22 Kit # 2170622 Exp. 23-Nov-23, Pouch Lot # 2N6S22 Kit # 2170722 Exp. 23-Nov-23, Pouch Lot # 2N6W22 Kit # 2171122 Exp. 21-Nov-23, Pouch Lot # 2N6X22 Kit # 2171222 Exp. 22-Nov-23, Pouch Lot # 2N7422 Kit # 2171922 Exp. 26-Nov-23, ;UDI-DI: UDI: 00815381020482

Distribution pattern

US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

device · product 2 of 2

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

Z-2440-2023
Recall number
Z-2440-2023
Initiated
May 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
BioFire Diagnostics, LLC
Quantity
24 Kits (30 pouches/kit)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to manufacturing issue, panels may result in false negative results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to manufacturing issue, panels may result in false negative results.

Code information

Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482

Distribution pattern

US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia