Class 2 Device Recall Panther Fusion Tube Trays

• Date Initiated by Firm: February 26, 2021
• Create Date: April 07, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1369-2021
• Recall Event ID: 87557
• Product Classification: Instrumentation for clinical multiplex test systems - Product Code NSU
• Product: Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
• Code Information: Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545
• Recalling Firm/ Manufacturer: Hologic, Inc; 10210 Genetic Center Dr; San Diego CA 92121-4362
• For Additional Information Contact: Hologic Technical Support; 888-484-4747
• Manufacturer Reason for Recall: There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On February 26, 2021, Hologic, issued "Urgent: Medical Device Recall Notification" to affected consignees via FedEx. In addition, to informing consignees about the recall, they asked customers to take the following actions: Laboratory Action: A. Please immediately discontinue use of the Panther Fusion Tube Tray lots listed in Table 1. B. Please immediately check your inventory and segregate the Panther Fusion Tube Tray lots listed in Table 1. C. The number of tube tray boxes shipped to your site is identified on the accompanying document. (GBS customers will receive a blank form and will need to fill in lot number and quantity.) - Please fill out the documents completely, including the number of boxes of the specified lots remaining in inventory (whether unopened or partial boxes). - After completing the document, destroy the segregated inventory. - Sign the document to signify compliance and return it as instructed on the document. - Please do this even if you do not have any of the affected trays remaining in your inventory. D. Hologic will ship replacement product to your site based on the number of boxes of the specified lots you list as remaining in your inventory on the document you return. E. Please ensure that appropriate laboratory personnel are notified of the information herein. F. If you have any questions or concerns about this notification or about the replacement product, please contact Hologic Technical Support at 1888-484-474- or molecularsupport@hologic.com
• Quantity in Commerce: 1355 kits
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).
• 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.