Z-1713-2017 Class II Terminated
FDA device recall Z-1713-2017 was initiated by BioMerieux SA on March 7, 2017 and is designated Class II. Reason for recall: Problem with colored eluates for whole blood extractions The recall status is terminated (terminated August 18, 2020). Affected quantity: 1025.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- August 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1025
Product Description
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Reason for Recall
Problem with colored eluates for whole blood extractions
Distribution Pattern
Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.
Code Information
Lot Number 16092902