Hologic, Inc: Medical Device Recall in 2022 - (Recall #: Z-0877-2022)

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 GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

Product Classification:

Class II

Date Initiated: March 18, 2022

Date Posted: April 13, 2022

Recall Number: Z-0877-2022

Event ID: 89855

Reason for Recall:

Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

Status: Ongoing

Product Quantity: 2061

Code Information:

UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353

Distribution Pattern:

US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA

Voluntary or Mandated:

Voluntary: Firm initiated