Hologic, Inc: Medical Device Recall in 2022 - (Recall #: Z-0750-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

Product Classification:

Class II

Date Initiated: January 27, 2022

Date Posted: March 23, 2022

Recall Number: Z-0750-2022

Event ID: 89533

Reason for Recall:

Failed stability specifications for reagent kits that may result in false negative test results.

Status: Ongoing

Product Quantity: 264 kits

Code Information:

Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated