FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a diagnostic test with potential for false positive results. The hazard is theoretical (no reported illnesses or injuries), but the product represents a risk-of-harm where diagnostic inaccuracy could lead to patient harm through misdiagnosis.
Plain-English summary
BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel Plus (Pneumoplus) diagnostic test kits (REF: RFIT-ASY-0143, CED 2797) due to a potential for false positive results.
The affected kits include all unexpired lots, with approximately 214,080 pouches distributed worldwide. In the United States, the tests were distributed to all 50 states, the District of Columbia, and Puerto Rico. Internationally, distribution includes Argentina, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, and Venezuela.
False positive results could lead to incorrect diagnosis of pneumonia in patients who do not have the condition. If you have questions about this recall, contact your healthcare provider for guidance.
The recalled product
- Product
- FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 214,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00815381020314/ All unexpired lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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