Class II — Hologic, Inc
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. |
| Quantity | 2061 |
| 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 |
| Initiated | 2022-03-18 |
| Classified | 2022-04-06 |
| Recall number | Z-0877-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc (Z-0877-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89855/
Alerts for HOLOGIC, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.