Hologic, Inc: Medical Device Recall in 2021 - (Recall #: Z-1369-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

Product Classification:

Class II

Date Initiated: February 26, 2021

Date Posted: April 14, 2021

Recall Number: Z-1369-2021

Event ID: 87557

Reason for Recall:

There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.

Status: Ongoing

Product Quantity: 1355 kits

Code Information:

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

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).

Voluntary or Mandated:

Voluntary: Firm initiated