Panther Fusion Extraction Reagent-S — Class II medical device recall Z-2163-2020
Ongoing recall by Hologic, Inc, reported 2020-06-03, distributed in AR, CA, FL, ID, IL, IN, LA, NM…. Reagent component included in flu test kit may cause both high background signal in a true negative sample lea
| Recall number | Z-2163-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, San Diego, CA, United States |
| Recall initiated | 2019-10-10 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Distributed | AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI |
| Quantity | 47 kits |
| UPC / GTIN / UDI-DI | 15420045509214 |
| Lot numbers | 257472, 257473, 258402 |
| Model numbers | PRD-04331 |
Product
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214
Reason for recall
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
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-2163-2020. 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.