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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0993-2024 |
| Event ID | 93592 |
| Event Description | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) |
| Product Type | Devices |
| Distribution | Worldwide - 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. |
| Quantity | 214,080 pouches |
| Recall Reason | Their is a potential for false positive results when using Pneumonia panel. |
| Device Classification | 20240214 |
| Device Code Info | UDI: 00815381020314/ All unexpired lots |
| Center Classification Date | 20240206 |
| Recall Initiation Date | 20231214 |
| Recalling Firm | BioFire Diagnostics, LLC |
| Initial Notification | Letter |
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