BD CD3 — Class III medical device recall Z-0171-2016
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2015-11-04, distributed nationwide. Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
| Recall number | Z-0171-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2015-09-30 |
| Classified | 2015-10-27 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 120 units |
| Reason classes | labeling |
| Lot numbers | 5113983, 5148598 |
| Model numbers | 340542, 349201 |
| Expiration dates | 2016-10-31, 2017-02-28 |
Product
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Reason for recall
Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
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-0171-2016. 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.