FDA Enforcement
Class II
Ongoing
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Recall: Z-0877-2022
·
Reported April 13, 2022
Enforcement
- Recall Number
- Z-0877-2022
- Event ID
- 89855
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hologic, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 13, 2022
- Initiation Date
- March 18, 2022
- Classification Date
- April 6, 2022
- Address
- 10210 Genetic Center Dr, San Diego, CA, 92121-4362, United States
Description
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
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 Info
UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
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
Quantity
2061