Recall Z-1713-2017— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2017-03-07, terminated 2020-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens. Reason: Problem with colored eluates for whole blood extractions.
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-07
- Terminated
- 2020-08-18
- Firm location
- Marcy L'Etoile, N/A, France
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.