FDAFDA · Food and drugs·Recall number Z-0877-2022
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Published April 13, 2022 · Recall initiated: March 18, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc
- Distributor
- 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
- UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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