Z-0312-2022Class II

BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture...

Name: Z-0312-2022 BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture...
Creator: BioFire Diagnostics, LLC
Published: 2021-10-11
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2021-10-11 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus... on 2021-10-11. FDA classified it as Class II and gives the reason as "Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials". 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-0312-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-11
Posted: 2021-11-30
Terminated: 2023-08-10
Recalling firm: BioFire Diagnostics, LLC
Product: BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On or about 10/10/2021, the Recalling Firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to U.S. customer via overnight FedEx to inform them that there is an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results when the blood culture identification panels are used with some types of blood culture vials. The increased risk are potential due to an increased level of nucleic acid from non-viable Acinetobacter calcoaceticus- baumannii complex targets in the blood culture vials. Affected Blood Culture Media vials are: 442023 - BD BACTEC Plus Aerobic medium in plastic vials; 442021 - BD BACTEC Lytic Anaerobic medium in plastic vials; 442192 - BD BACTEC Plus Aerobic medium in glass vials; 442022 - BD BACTEC Plus Anaerobic medium in plastic vials; 442020 - BD BACTEC Peds Plus mediums in plastic vials; Customers are instructed to: 1) If the BCID2 Panel is used to test BD BACTEC" blood culture vials with an expiration date of April 30, 2022 or earlier, positive results for Acinetobacter calcoaceticus- baumannii complex should be confirmed by another method prior to reporting the test results. 2) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to the Recalling Firm via one of the listed return methods so that the Recalling Firm may acknowledge their receipt of this notification. Any questions or concerns, contact customer support department at [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support.
Quantity in commerce: Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. The Countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Dominican Rep/, Ecuador, Egypt, France, Georgia, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Israel Italy, Kuwait, Latvia, Macedonia, Malaysia, Mexico, Netherlands, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Shanghai, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/.
Product codes and lots: Blood Culture Identification 2 (BCID2) Panel Part Number: RFIT-ASY-0147 UDI Code: 00815381020338 Blood Culture Media Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All BCID2 Panel lots BD Blood Culture Media vials with expiration date of April 30, 2022 or earlier.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0312-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0312-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-11-30

Product code PEN

K193519Class IIBioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC / cleared 2020-03-18

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)