Hologic, Inc recalls Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to t

Recalled April 14, 2021 · FDA recall Z-1369-2021 · Hologic

Hazard

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

Units

1355 kits

Sold at

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).

Description

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

Product

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.

Manufacturer(s)

Hologic, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →