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Terminated

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

FDA Recall Z-1157-2021 · Posted None

Recalling FirmBioFire Diagnostics, LLC
Recall StatusTerminated
Product CodePEN
Date Initiated2021-01-26
Date Terminated2022-05-02
Product Quantity21,922 kits

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC · 2018-07-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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