BioFire Diagnostics, LLC: FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Bl

Is my product affected?

FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

• UPC 00815381020086
• UPC 00815381020093

Check against the official notice below — it lists the full affected range.

What happened

BioFire Diagnostics, LLC has recalled the FilmArray BCID Panel (Blood Culture Identification Panel), catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), due to an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. All lot numbers of the FilmArray BCID Panel are affected. The recalled product was distributed nationwide in the United States, to the military and government agencies, and internationally to countries including Canada, Australia, France, Germany, India, Israel, Japan, and many others.

The recall affects BD BACTEC Blood Culture Bottles with expiration dates of September 30, 2018 and beyond. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.

Details from the source

Reason for recall: There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. Distribution: Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Ku Quantity: N/A Lot/code info: All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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