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Recall Observatory FDA recall evidence

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

March 07, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    Problem with colored eluates for whole blood extractions