Z-0877-2022 Class II Ongoing
FDA device recall Z-0877-2022 was initiated by Hologic, Inc on Mar 18, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2061.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Mar 18, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0877-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026