FilmArray BCID Panel recall
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog…
Why was FilmArray BCID Panel recalled?
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.
- Product
- FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog…
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 5,020 kits
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austria, Australia, Azerbaijan, Belgium, Bosnia-Herz., Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Columbia, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Gabon, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Phillipines, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Sitzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)