Class 2 Device Recall RapidfFN for the TLiIQ(R) System

• Date Initiated by Firm: November 29, 2017
• Create Date: February 21, 2018
• Recall Status: Terminated on August 22, 2018
• Recall Number: Z-0676-2018
• Recall Event ID: 78832
• PMA Number: P920048
• Product Classification: Enzyme immunoassay, fetal fibronectin - Product Code LKV
• Product: Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
• Code Information: K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082
• Recalling Firm/ Manufacturer: Hologic, Inc.; 1240 Elko Dr; Sunnyvale CA 94089-2212
• For Additional Information Contact: Kathy Chester; 408-745-0975 Ext. 128
• Manufacturer Reason for Recall: Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.
• Quantity in Commerce: 165 kits
• Distribution: United States (US), Guam (GU), Japan (JP)
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LKV