Z-0148-2027 Class II Ongoing
FDA device recall Z-0148-2027 was initiated by BioFire Diagnostics, LLC on Aug 12, 2026 and is designated Class II. Reason for recall: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results The recall status is ongoing. Affected quantity: 4,892.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Aug 12, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,892
Product Description
Reason for Recall
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, 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, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0148-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026