Z-0750-2022 Class II Ongoing
FDA device recall Z-0750-2022 was initiated by Hologic, Inc on Jan 27, 2022 and is designated Class II. Reason for recall: Failed stability specifications for reagent kits that may result in false negative test results. The recall status is ongoing. Affected quantity: 264 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Jan 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 264 kits
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.
Code Information
Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0750-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026