Hologic recalls 18-count Panther Fusion Tube Trays (PN: FA-15004) that may leak, causing false positive/negative test results. Affected units sold with specific lot numbers.
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Hologic is recalling 18-count Panther Fusion Tube Trays that could leak during use. This might lead to inaccurate test results, which could affect patient care.
The tube trays may leak during use, which could cause test results to be false positives, false negatives, or invalid. This might lead to incorrect patient diagnoses or treatment decisions.
Lab technicians and healthcare providers using the Panther Fusion System for PCR testing are most at risk. Patients could be affected if tests are inaccurate.
Check for the product code FA-15004 (PN) with lot numbers listed in the description. The trays are sold as ancillary consumables for the Panther Fusion System.
Inspect the tube trays for signs of leakage before use.
The tube trays may leak during use, which could cause false positive or negative test results.
The recall record does not specify a remedy, so check for leaks and contact Hologic if concerns arise.
Yes, the recall includes specific lot numbers like 285762, 285765, 286025, and others listed in the product description.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1369-2021 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1369-2021 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.
