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U.S. Department of Health and Human Services

Class 2 Device Recall Panther Fusion Extraction reagentX

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  Class 2 Device Recall Panther Fusion Extraction reagentX see related information
Date Initiated by Firm January 27, 2022
Create Date March 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0750-2022
Recall Event ID 89533
Product Classification System, transport, aerobic - Product Code JTW
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
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
Recalling Firm/
Manufacturer		 Hologic, Inc
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact Hologic Technical Support
1888-410-8250
Manufacturer Reason
for Recall		 Failed stability specifications for reagent kits that may result in false negative test results.
FDA Determined
Cause 2		 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 remaining in the inventory. 5. If any of the specified kits remain in inventory (whether unopened or partial kits containing used reagent), to contact Hologic Technical Support. To destroy the segregated inventory After returning the completed CRF. 6. After returning the completed CRF, please destroy the segregated inventory. When this documentation is complete, please fax the CRF to Hologic Technical Support using this fax number: +1 858 410 8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com 8. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 88 484 474 or +1 858410 8511 during the hours of 5 AM PDT - 5 PM PDT, or by e-mail at molecularsupport@hologic.com
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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