FDA recall Z-2990-2020

Hologic, Inc · Class II · device

Product

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

Reason for recall

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.

Distribution

U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT

Key facts

Status: Terminated
Initiation date: 2020-08-04
Report date: 2020-09-30
Termination date: 2024-12-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2990-2020