Z-0877-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- March 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2061
Product Description
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Reason for Recall
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
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
Code Information
UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353