Reported Apr 14, 2021 · Ongoing
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- Panther Fusion Tube Tray, REF PRD-04000
- PN
FA-15004Cont. 18
- Tube Trays - Product Usagean ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing
- Lot codes and dates
- Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545
- Amount recalled
- 1355 kits
Where it was sold
Why it was recalled
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
This product could cause temporary or reversible health problems — stop using it.
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