Z-0822-2019 Class III Terminated
FDA device recall Z-0822-2019 was initiated by Luminex Corporation on Dec 26, 2018 and is designated Class III. Reason for recall: On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label. The recall status is terminated (terminated Aug 4, 2020). Affected quantity: 1132 carriers.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 20, 2019
- Initiation Date
- Dec 26, 2018
- Termination Date
- Aug 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1132 carriers
Product Description
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.
Reason for Recall
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Code Information
UDI: 00857573006287, Lots: 110318018C, 111018018D
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0822-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026