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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68352

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

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Event summary

Timeline bucket
May 27, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BioFire Diagnostics, 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.

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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

FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria, gram-negative bacteria, and yeast are identified using the FilmArray BCID Panel: Enterococci, Listeria monocytogenes, commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus), commonly encountered Streptococci (with specific differentiation of Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes), Acinetobacter baumannii, commonly encountered Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens), Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, and Candida tropicalis. The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA), vancomycin (vanA and vanB), and carbapenems (blaKPC) to aid in the identification of potentially antimicrobialresistant organisms in positive blood culture samples.

Z-1843-2014
Recall number
Z-1843-2014
Initiated
May 27, 2014
Classification
Class II
Status
Terminated
Recalling firm
BioFire Diagnostics, Inc.
Quantity
1084

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

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Inspect official wording and provenance

Reason for recall

BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.

Code information

426614,424514,424014,421114,419114,419214,417814,416214,416114,411214,411314,411014,410414,410014,408414,406314,404314,402314,403613,700113,698513,695313,692813,689813,689113,686313,685313,677713,668613,665013,667213,667113,663313,663013,665913,657313,659613,651413,647513,644613,632713,424614,424114,419514,419614,418014,416314,416414,412014,412114,411914,409914,406214,404414,700013,698413,695413,692913,689213,685413,668713,665113,667313,662913,657213,663913,660213,651513,647313,622213,

Distribution pattern

Worldwide Distribution - USA (nationwide) European Union, Hong Kong, and VA.

Field note

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