Recall Z-0750-2022— Hologic, Inc
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc, initiated 2022-01-27. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Failed stability specifications for reagent kits that may result in false negative test results..
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-27
- Firm location
- San Diego, CA, United States
Product description
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
Reason for recall
Failed stability specifications for reagent kits that may result in false negative test results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.