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BioFire Diagnostics, LLC Recall 93592

Description: FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

BioFire Diagnostics, LLC Recall 93592 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0993-2024
Event ID93592
Event DescriptionFilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Product TypeDevices
DistributionWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, 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, Venezuela.
Quantity214,080 pouches
Recall ReasonTheir is a potential for false positive results when using Pneumonia panel.
Device Classification20240214
Device Code InfoUDI: 00815381020314/ All unexpired lots
Center Classification Date20240206
Recall Initiation Date20231214
Recalling FirmBioFire Diagnostics, LLC
Initial Notification Letter
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