Panther Fusion GBS Assay Cartridges 96 Tests — Class II medical device recall Z-0877-2022
Ongoing recall by Hologic, Inc, reported 2022-04-13, distributed in AR, CA, CT, FL, IL, IN, MA, MI…. Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may p
| Recall number | Z-0877-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2022-03-18 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Distributed | AR, CA, CT, FL, IL, IN, MA, MI, NH, NJ, NV, NY, OR, PA, PR, TN, TX, UT, VA, WA, WV |
| Quantity | 2,061 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15420045510890 |
| Lot numbers | 274954, 284599, 296991, 300796, 309230, 309353 |
| Model numbers | PRD-04484 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0877-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.