FDA Device recall Z-1676-2015
D2-40 (Lymphatic Marker)
- FDA Device
- Class III
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class III recall of D2-40 (Lymphatic Marker) by Biocare Medical, citing firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1676-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-05-06 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biocare Medical |
| Distribution | US |
Product
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
Reason
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Identifiers
| code_info | Catalog number: PM266AA, lot 030615, Expiration: 2018/03. |
|---|
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-1676-2015%22
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