Hologic Panther Fusion Extraction Reagent-S Recalled for False Test Results
Hologic is recalling Panther Fusion Extraction Reagent-S kits because a reagent component may cause false positive or negative flu test results, potentially delaying treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect diagnostic results (false positives/negatives) which could delay treatment, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hologic, Inc. is recalling 47 kits of Panther Fusion Extraction Reagent-S (Ref PRD-04331). The recall involves specific lots of the Panther Fusion Capture Reagent-S and Panther Fusion Enhancer Reagent-S. The affected products were distributed in the United States (AR, CA, FL, ID, IL, IN, LA, NM, NY, PA, TX, UT, VI, WA, WI) and internationally (AU, CA).
The recall was initiated because a reagent component included in the flu test kit may cause high background signal in true negative samples. This defect can lead to false positive or false negative results on patient samples or failed controls, resulting in invalid runs. Consequently, incorrect results may be reported, which could lead to a delay in patient treatment.
Healthcare facilities and laboratories should stop using the affected lots immediately. Users should contact Hologic for instructions on returning the product or obtaining a replacement. Consumers should consult their healthcare provider if they have received test results using these specific kits.
The recalled product
- 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
- Manufacturer
- Hologic, Inc
- Affected units
- 47
Distribution
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