Recall Z-1580-2016 ยท NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Hologic, Inc
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
| Date | Mar 31, 2016 |
| Status | Terminated |
| 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. |
| Root 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 c |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063787 | INPLEX CF MOLECULAR TEST Third Wave Technologies, Inc., Mar 13, 2008 |