Vergene Amplification Tray — Class III medical device recall Z-0822-2019

Terminated recall by Luminex Corporation, reported 2019-02-20, distributed nationwide. On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray lab

Recall number	`Z-0822-2019`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Luminex Corporation, Austin, TX, United States
Recall initiated	2018-12-26
Classified	2019-02-11
Reported by FDA	2019-02-20
Terminated	2020-08-04
Distributed	Nationwide (US)
Countries outside the US	AT, IT
Quantity	1,132 carriers
Reason classes	labeling
UPC / GTIN / UDI-DI	`00857573006287`
Lot numbers	`110318018C`, `111018018D`
Model numbers	`20-011-018`

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0822-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.