Class 2 Device Recall Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD04484

• Date Initiated by Firm: March 18, 2022
• Date Posted: April 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0877-2022
• Recall Event ID: 89855
• 510(K)Number: K181156
• Product Classification: Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
• Product: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
• Code Information: UDI: 15420045510890, Lot numbers: 274954, 284599, 296991, 300796, 309230, 309353
• 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: Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
• FDA Determined Cause: Component change control
• Action: On 03/18/22, recall notices were sent to customers who were informed that the recalling firm is discontinuing the further sale of the affected GBS Assay for the foreseeable future. Customers were asked to do the following: 1) Discontinue use and destroy affected GBS assay kit lots and respective components. 2) Complete and return the customer response form. Customers with additional questions were encouraged to contact Technical Support at +1 888 484 4747 or +1 858 410 8511 between 5am PDT and 5 pm PDT, or by email at molecularsupport@hologic.com
• Quantity in Commerce: 2061
• Distribution: US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA
• 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.

• 510(K) Database: 510(K)s with Product Code = NJR