BioFire Diagnostics, LLC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
Products Sold
All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
BioFire Diagnostics, LLC is recalling Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (B due to The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood cul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026