Anti-Lambda APC-H7 — Class II medical device recall Z-1002-2015
Terminated recall by BD Biosciences, Systems & Reagents, reported 2015-01-28, distributed nationwide. Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
| Recall number | Z-1002-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD Biosciences, Systems & Reagents, San Jose, CA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-01-20 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2016-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Lot numbers | 4155632, 42889687 |
| Model numbers | 656157 |
| Expiration dates | 2015-06-30 |
Product
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Reason for recall
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
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-1002-2015. 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.