Panther Fusion recallZ-0877-2022 · Hologic, Inc · initiated Mar 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
FDA root cause category: Component change control
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0877-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 18, 2022
- Posted by the FDA
- Apr 6, 2022
- Recalling firm
- Hologic, Inc
- Quantity
- 2061
- Product code
- NJR
- FDA submissions
- K181156
- 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
Product description
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Code information (models, lots, serial numbers)
UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Panther Fusion® KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVDHologic, Inc. · real time Nucleic acid amplification system2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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