Hologic Panther Fusion Extraction Reagent-X May Produce False Test Results
Hologic is recalling Panther Fusion Extraction Reagent-X kits due to failed stability specifications that may cause false negative test results. Healthcare providers should stop using affected lots.
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: This is an FDA Class II medical device recall where failed stability in diagnostic reagent kits may result in false negative test results, representing a risk-of-harm product without reported injuries or illnesses.
Plain-English summary
Hologic, Inc is recalling Panther Fusion Extraction Reagent-X kits (REF PRD-04477) used with the Panther Fusion System. The reagent kits failed to meet stability specifications, which may result in false negative test results when using the Panther Fusion System.
The affected reagent kits were distributed worldwide to locations in the United States, Canada, Australia, Belgium, Netherlands, China, Italy, Germany, and Sweden. A total of 264 kits are affected, including specific lot numbers for the Fusion Capture Reagent-X (FCR-X) and Fusion Enhancer Reagent-X (FER-X) components.
Healthcare facilities and laboratories using affected lot numbers should stop using these reagent kits immediately and contact Hologic for instructions on obtaining replacement reagents.
The recalled product
- Product
- Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
- Manufacturer
- Hologic, Inc
- Affected units
- 264
Distribution
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