Luminex Vergene Amplification Tray Recall: Labeling Error Risk
Luminex recalls Vergene Amplification Tray (700uL, BC-GP REF 20-011-018) due to labeling error on Verigene Gram-Positive Blood Culture Nucleic Acid Test kits. Affected units have specific UDI and lot numbers.
Lower-risk recall
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
Contact the company
What happened, in plain English
Luminex is recalling Vergene Amplification Trays with the model number 700uL, BC-GP REF 20-011-018 due to a labeling error. This could lead to incorrect use of the Verigene Gram-Positive Blood Culture Nucleic Acid Test kits, potentially causing inaccurate results in detecting bloodstream infections. Read more at govinfonow.com/recall/69205-luminex-vergene-amplification-tray-recall-labeling-error-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69205-luminex-vergene-amplification-tray-recall-labeling-error-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0822-2019
Cite this page
“Luminex Vergene Amplification Tray Recall: Labeling Error Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69205-luminex-vergene-amplification-tray-recall-labeling-error-risk. Based on FDA recall #Z-0822-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0822-2019%22&limit=1).
Why it’s dangerous
The labeling error means some Verigene BC-GP Utility Kits were incorrectly labeled with the Amplification Tray label. This could cause confusion during testing, potentially leading to inaccurate results for detecting gram-positive bacteria in blood cultures.
Who’s affected
Healthcare professionals using the Verigene Gram-Positive Blood Culture Nucleic Acid Test kits are most at risk. The recall affects specific units with UDI 00857573006287 and lots 110318018C, 111018018D.
How to tell if you have this one
Check for the UDI code 00857573006287 and lot numbers 110318018C or 111018018D on the product packaging. The product is the Verigene Gram-Positive Blood Culture Nucleic Acid Test kit with the Amplification Tray label.
- Brand
Luminex- Category
Medical device
What to do — step by step
Check Product Label
Look for the UDI code 00857573006287 and lot numbers 110318018C or 111018018D on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0822-2019 (December 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0822-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.