Z-1513-2018 Class II Terminated
FDA device recall Z-1513-2018 was initiated by BioFire Diagnostics, LLC on Mar 14, 2018 and is designated Class II. Reason for recall: There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. The recall status is terminated (terminated Oct 24, 2018).
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Mar 14, 2018
- Termination Date
- Oct 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Reason for Recall
Distribution Pattern
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.
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-1513-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026