FDA Medical Device Recalls (openFDA)
Hologic, Inc: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
- Recall number
- Z-0877-2022
- Recalling firm
- Hologic, Inc
- Product
- Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
- Status
- Open, Classified
- Initiated
- 2022-03-18
- Posted
- 2022-04-06
- Terminated
- not on file
- Reason
- Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
- Root cause
- Component change control
- Action
- 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
- Quantity
- 2061
- Distribution
- US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA
- Lot, serial or model codes
- UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
- 510(k) numbers
- ["K181156"]
- PMA numbers
- not on file
- Product code
- NJR
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28