Device product
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Z-1713-2017
Product summary
- Firm
- BioMerieux SA
- Event
- Event 76675
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1025
- Official record key
device-enforcement:Z-1713-2017
Official wording
Reason: Problem with colored eluates for whole blood extractions
Code information: Lot Number 16092902
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.
Derived failure modes
-
Unknown
Problem with colored eluates for whole blood extractions