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U.S. Department of Health and Human Services

Class 2 Device Recall Panther Fusion Reaction Tube

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 Class 2 Device Recall Panther Fusion Reaction Tubesee related information
Date Initiated by FirmAugust 04, 2020
Create DateSeptember 21, 2020
Recall Status1 Terminated 3 on December 23, 2024
Recall NumberZ-2990-2020
Recall Event ID 86248
Product Classification Instrumentation for clinical multiplex test systems - Product Code NSU
ProductPanther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Code Information Box/ Tray lots: 271436/ 618539,  271438/ 620899,  272089/ 620899,  272959/ 621837,  272970/ 621256,  272971/ 621837,  274670/ 625351  
FEI Number 2024800
Recalling Firm/
Manufacturer		 Hologic, Inc
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact
858-410-8000
Manufacturer Reason
for Recall		Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 08/04/20, Medical Device Recall Notifications were mailed to Laboratory Managers, Site Administrators, and Operators. Customers were asked to do the following: 1. Discontinue use. 2. Immediately check inventory and segregate affected devices. 3. Complete the customer response form. Document the remaining inventory. Destroy the segregated inventory. Return the customer response form even if there is no affected inventory present. 4. There is no other specific actions to the assays. 5. Recalling firm will ship replacement product based on the customer response form information.
Quantity in Commerce607
DistributionU.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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