FDAJanuary 26, 2021device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
biofire diagnosticsbiofire
UPCs
0081538102008600815381020093
Recall history
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