Class 2 Device Recall Jologic InPlex CF Molecular Test

• Date Initiated by Firm: March 31, 2016
• Create Date: April 27, 2016
• Recall Status: Terminated on August 09, 2016
• Recall Number: Z-1580-2016
• Recall Event ID: 73747
• 510(K)Number: K063787
• Product Classification: System, cystic fibrosis transmembrane conductance regulator, gene mutation detection - Product Code NUA
• Product: Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
• Code Information: Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)
• 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: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Customer notification letters were sent 03/31/16. Customers were instructed to immediately discontinue the use of the affected lot numbers. If a HET or MUT result was reported with the affected lots, Hologic recommends that customers notify the recipient of the result and request the patient be retested with another test method. Any HET or MUT results that were previously retested and reported out as negative do not require further testing. The firm requests that customers segregate any remaining inventory of all affected lots listed on the Customer Response Form. After segregation is complete reconcile the number of units (ASR Card or IVD Molecular Test Kit) which remain in inventory upon receipt of notification against the number originally shipped to site, and destroy all remaining inventory of the affected lots. Document the following in the appropriate fields on the Customer Response Form: 1. If have zero of the affected products on hand check the first box. 2. If have some inventory of the affected products on hand check the second box and then document the quantity on hand below, in the Qty On-Hand column. Note: When counting the number of units remaining in inventory count each unit (ASR Card box or IVD Molecular Test Kit), whether partial or full, as a unit. 3. Print name, phone and email address, in case the firm needs to follow up. 4. Sign and date the form. Signing acknowledges compliance with this recall notification, including destroying all remaining inventory of the affected products. When this documentation is complete fax the CRF to Hologic Technical Support using fax number: 858-410-8250. Alternatively, you can scan the document(s) and email to Hologic Technical Support at molecularsupport@hologic.com. If laboratory has shared any of the affected cards noted in the CRF with another laboratory contact Hologic Technical Support immediately using the phone number below, so that Hologic may contact the other laboratory t
• Quantity in Commerce: 2580 total
• Distribution: Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = NUA and Original Applicant = THIRD WAVE TECHNOLOGIES, INC.