Device product
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Z-0877-2022
Product summary
- Firm
- Hologic, Inc
- Event
- Event 89855
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2061
- Official record key
device-enforcement:Z-0877-2022
Official wording
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.
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
Derived failure modes
-
Unknown
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.