FDAFDA · Food and drugs·Recall number Z-0027-2018
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Published October 25, 2017 · Recall initiated: September 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Hologic, Inc
- Distributor
- Indiana
- Lot
- Serial Number 20900001124
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.