FDA Device recall Z-1580-2016
Hologic InPlex CF Molecular Test (IVD)
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Hologic InPlex CF Molecular Test (IVD) by Hologic, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1580-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, WA, WV |
Product
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
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.
Identifiers
| code_info | Lot Numbers: C33xx C34xx C35xx (xx denotes sublots) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1580-2016%22
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