FDA (Devices) recall action 87282
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
BioFire Diagnostics is recalling BCID2 Panels due to a risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC blood culture vials.
BioFire Diagnostics is recalling Film Array BCID Panels due to an increased risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC vials.