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.
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
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.
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.
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.
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.
Look for the UDI code 00857573006287 and lot numbers 110318018C or 111018018D on the product packaging.
The recall is due to a labeling error where some Verigene BC-GP Utility Kits were incorrectly labeled with the Amplification Tray label.
The affected product is the Vergene Amplification Tray with model number 700uL, BC-GP REF 20-011-018.
Check for the UDI code 00857573006287 and lot numbers 110318018C or 111018018D on the product packaging.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0822-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0822-2019 from Luminex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
