FDA Device recall Z-0877-2022
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus by Hologic, citing samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0877-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-18 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hologic |
| Distribution | AR, CA, CT, FL, IL, IN, MA, MI, NH, NJ, NV, NY, OR, PA, PR, TN, TX, UT, VA, WA, WV |
Product
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.
Identifiers
| code_info | UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0877-2022%22
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