Z-0994-2024 Class II Ongoing
FDA device recall Z-0994-2024 was initiated by BioFire Diagnostics, LLC on December 14, 2023 and is designated Class II. Reason for recall: Their is a potential for false positive results when using Pneumonia panel. The recall status is ongoing. Affected quantity: 274,290 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274,290 units
Product Description
Reason for Recall
Distribution Pattern
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.