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Recall Observatory FDA recall evidence

Device product

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

Z-0822-2019

December 26, 2018

Class III

Product summary

Firm
Luminex Corporation
Event
Event 81890
Status
Terminated
Classification
Class III
Quantity
1132 carriers
Official record key
device-enforcement:Z-0822-2019

Official wording

Reason: On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

Code information: UDI: 00857573006287, Lots: 110318018C, 111018018D

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.