Recall Z-0750-2022 ยท JTW System, Transport, Aerobic
Hologic, Inc
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
| Date | Jan 27, 2022 |
| Status | Open, Classified |
| Reason | Failed stability specifications for reagent kits that may result in false negative test results. |
| Root cause | Unknown/Undetermined by firm |
| Action | on 2/3/22 Hologic issued a "Urgent: Medical Device Recall Notification" via FedEx. In addition to informing consignees about the recall, the firm ask consignees to take the following action: 1. Immediately discontinue use of the lot of Panther Fusion Extraction Reagent-X kits and respective components 2. Immediately check their inventory and segregate the Panther Fusion Extraction Reagent-X kit lot 3. The number of kits shipped to the site is identified on the accompanying Customer Response Form (CRF). 4. Return the completed CRF to Hologic Technical Support, even if none of the kits re |
| Quantity | 264 kits |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.