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U.S. Department of Health and Human Services

Class 2 Device Recall Panther Fusion GBS (Group B Streptococcus) Assay

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 Class 2 Device Recall Panther Fusion GBS (Group B Streptococcus) Assaysee related information
Date Initiated by FirmDecember 13, 2024
Date PostedJanuary 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0907-2025
Recall Event ID 95948
510(K)NumberK181156 
Product Classification Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
ProductPanther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Code Information UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.
FEI Number 2024800
Recalling Firm/
Manufacturer		 Hologic, Inc.
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information ContactRyan Simon
858-275-0032 Ext. 128
Manufacturer Reason
for Recall		Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
FDA Determined
Cause 2		Process control
ActionAn Urgent Medical Device Recall Notification letter issued 12/13/2024 via Fed Ex. The letter instructs customers to discontinue use of the Panther Fusion GBS Assay kit lot 715927 containing cartridge lot 624907 and segregate and count the number of affected Panther Fusion GBS Assay kits from lot 715927 containing cartridge lot 624907. Customers are instructed to destroy the product and fill out the online Customer Response Form (CRF) indicating that the on-hand inventory of recalled Panther Fusion GBS Assay Kit has been destroyed. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 888 484 4747 or +1 858 410 8511 during the hours of 5 am PT and 5 pm PT, or by e-mail at molecularsupport@hologic.com.
Quantity in Commerce380
DistributionAR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NJR
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