FDA Device recall Z-2113-2014
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use by Biogenex Laboratories, citing product was distributed without 510(k) approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2113-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-01 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biogenex Laboratories |
| Distribution | n/a |
Product
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Reason
Product was distributed without 510(k) approval.
Identifiers
| code_info | Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2113-2014%22
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