Reported Jun 3, 2020 · Ongoing
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S,…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- 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)
- UDI15420045509214
- Lot codes and dates
- Panther
- Fusion Extraction Reagent-S Lot number258402 Panther
- Fusion Capture Reagent-S Lot number257472 Panther
- Fusion Enhancer Reagent-S Lot number257473
- Amount recalled
- 47 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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