Z-0446-2019Class II

-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For...

Name: Z-0446-2019 -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For...
Creator: BioFire Diagnostics, LLC
Published: 2018-09-10
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2018-09-10 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE... on 2018-09-10. FDA classified it as Class II and gives the reason as "Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0446-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-10
Posted: 2018-11-10
Terminated: 2021-04-28
Recalling firm: BioFire Diagnostics, LLC
Product: -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Product code: PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Reason for recall: Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 09/10/2018, the firm sent an Urgent Medical Device Recall Letter via FedEx to the Recall Coordinator/Laboratory Director for all consignees. Consignees are instructed to: -Immediately examine their inventory for products with the affected Lot numbers and to discontinue use and to discard any remaining product in their possession that is subject to the recall.. BioFire will replace discarded product at no charge. -If the consignee has further distributed the affected product, they are to identify these customers and to notify them at once of the product recall. -Complete and return the Acknowledgement of Receipt Form that was enclosed with the Customer Advisory Notice letter, as soon as possible, and to return the Acknowledgement Form to the firm. Consignees were provided with firm contact information including phone numbers: 801-736-6354 and 1-800-735-6544
Quantity in commerce: 1350 pouches
Distribution: Worldwide Distribution - US Nationwide in the states of: CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI. International: Canada, Columbia and Mexico
Product codes and lots: ME Panel Kit Lot No. ME Pouch Lot. No. Kit Expiration Date 580818 892018 4/2/2019 584418 896018 4/5/2019 Note - Kits contain a Primer Pill Lot 210318. The Primer Pill is a freeze dried/lyophilized "pellet" that contains all of the primers and buffer used in the PCR1 reaction.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0446-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0446-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code PLO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)