Luminex recalls specific VERIGENE Nucleic Acid Test Kit extraction trays due to potential no call internal control failures from missing reagents. Affected units include lot 101321021B.
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Luminex is recalling a specific extraction tray for nucleic acid tests because a small subset of units may have missing reagents, causing no call internal control failures. This could lead to inaccurate test results if the tray is used without proper reagent levels.
The extraction tray may have missing reagents in a small subset of units, leading to no call internal control failures. This means the test results could be inaccurate if the tray is used without the proper reagent levels.
Users of the VERIGENE Nucle:ic Acid Test Kit-BC-GN Extraction Tray with lot number 101321021B are affected. Laboratory personnel and healthcare providers using this specific tray model are most at risk.
Check for the lot number 101321021B on the VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray (9.73 mL, REF 20-009-021).
Look for the lot number 101321021B on the extraction tray packaging or label.
The recall is due to a potential missing reagent in a small subset of units, which could cause no call internal control failures.
Check for the lot number 101321021B on the VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray (9.73 mL, REF 20-009-021).
The recall record does not specify a remedy, so contact Luminex Corporation for further instructions.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1109-2022 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1109-2022 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.
