Hologic, Inc Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Brand
Hologic, Inc
Lot Codes / Batch Numbers
UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
Products Sold
UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
Hologic, Inc is recalling Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test f due to Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Recommended Action
Per FDA guidance
On 03/18/22, recall notices were sent to customers who were informed that the recalling firm is discontinuing the further sale of the affected GBS Assay for the foreseeable future. Customers were asked to do the following: 1) Discontinue use and destroy affected GBS assay kit lots and respective components. 2) Complete and return the customer response form. Customers with additional questions were encouraged to contact Technical Support at +1 888 484 4747 or +1 858 410 8511 between 5am PDT and 5 pm PDT, or by email at molecularsupport@hologic.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, CT, FL, IL, IN, MA, MI, NV, NH, NJ, NY, OR, PA, TN, TX, UT, VA, WA, WV, PR
Page updated: Jan 10, 2026