Events

Recall of Device Recall Jologic InPlex CF Molecular Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73747
  • Event Risk Class
    Class 2
  • Event Number
    Z-1580-2016
  • Event Initiated Date
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144865
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, cystic fibrosis transmembrane conductance regulator, gene mutation detection - Product Code NUA
  • Reason
    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.
  • 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

Device

Device Recall Jologic InPlex CF Molecular Test
  • Model / Serial
    Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
  • Manufacturer
    Hologic, Inc

Manufacturer

Hologic, Inc
  • Manufacturer Address
    Hologic, Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA