Z-1513-2018Class II

FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and...

Name: Z-1513-2018 FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and...
Creator: BioFire Diagnostics, LLC
Published: 2018-03-14
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2018-03-14 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots... on 2018-03-14. FDA classified it as Class II and gives the reason as "There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles". 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-1513-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-04-25
Terminated: 2018-10-24
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018.
Distribution: Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.
Product codes and lots: All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1513-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25

Product code PEN

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)