D2-40 — Class III medical device recall Z-1676-2015
Terminated recall by Biocare Medical, LLC, reported 2015-06-03, distributed nationwide. Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
| Recall number | Z-1676-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Concord, CA, United States |
| Recall initiated | 2015-05-06 |
| Classified | 2015-05-26 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2015-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, ES, HU |
| Quantity | 19 units |
| Lot numbers | 030615, 2018/03 |
| Model numbers | PM266AA |
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 for recall
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1676-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.