FDAFDA · Food and drugs·Recall number Z-2113-2014
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Published July 30, 2014 · Recall initiated: July 1, 2014
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
Product was distributed without 510(k) approval.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Biogenex Laboratories, Inc.
- Distributor
- Brazil and Ecuador. No US distribution
- Lot
- Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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