Z-1157-2021Class II

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID)...

Name: Z-1157-2021 Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID)...
Creator: BioFire Diagnostics, LLC
Published: 2021-01-26
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2021-01-26 / Terminated

FDA source

BioFire Diagnostics, LLC began a recall of Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for... on 2021-01-26. FDA classified it as Class II and gives the reason as "The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1157-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-26
Posted: 2021-03-01
Terminated: 2022-05-02
Recalling firm: BioFire Diagnostics, LLC
Product: Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
FDA root cause: Other
Action: On or around January 25, 2021, the firm send an UGENT: MEDICAL DEVICE CORRECTION letter via email to all affected consignees. The firm's recall strategy includes notification of all customers who have ordered the BCID or BCID2 Panel, within the last 12 months, using the aforementioned Customer Letters. The effectiveness of this communication will be verified by monitoring confirmation of the Acknowledgment of Receipt from each affected customer.
Quantity in commerce: 21,922 kits
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.
Product codes and lots: All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1157-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1157-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-01
Z-1158-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-01

Product code PEN

K181493Class IIFilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC / cleared 2018-07-05

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)