FDA Device recall Z-2163-2020
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buff…
- FDA Device
- Class II
- ongoing
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buff… by Hologic, citing 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 resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2163-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-10 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hologic |
| Distribution | AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, WA, WI |
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
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.
Identifiers
| code_info | Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fu…Panther Fusion Extraction Reagent-S Lot number: 258402 Panther Fusion Capture Reagent-S Lot number: 257472 Panther Fusion Enhancer Reagent-S Lot number: 257473 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2163-2020%22
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