Hologic recalls Panther Fusion Tube Tray (FAB-15004) due to potential leaks causing false negative results in flu, RSV, and paraflu assays. Affected units include specific box/tray lots listed in the recall notice.
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
Hologic is recalling Panther Fusion Tube Trays with part number FAB-15004 because they may leak, leading to false negative results in flu, RSV, and paraflu tests. This could delay patient results and cause inaccurate test outcomes.
The tube trays may leak during use, which can cause false negative results in flu, RSV, and paraflu assays. This means tests might show negative when they should be positive, leading to delayed or incorrect patient results.
Laboratory users who have the Panther Fusion Tube Tray (FAB-15004) with specific box/tray lots listed in the recall notice. Those performing flu, RSV, or paraflu assays are most at risk of inaccurate results.
Check the box/tray lot numbers listed: 271436/618539, 271438/620899, 272089/620899, 272959/621837, 272970/621256, 272971/621837, 274670/625351. The product is sold under the Hologic brand.
Look for the box/tray lot numbers listed in the recall notice: 271436/618539, 271438/620899, 272089/620899, 272959/621837, 272970/621256, 272971/621837, 274670/625351.
The tube trays may leak, which can cause false negative results in flu, RSV, and paraflu assays, leading to delayed or inaccurate patient results.
Check the box/tray lot numbers listed in the recall notice to see if your unit is affected. If it is, contact Hologic for further instructions.
The recall is for potential inaccurate test results, not physical safety risks. There is no immediate danger to users from the product itself.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-2990-2020 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-2990-2020 from Hologic. 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.
