BD FMC7 FITC: Model 430918 — Class III medical device recall Z-0851-2016
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-03-02, distributed nationwide. Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date li
| Recall number | Z-0851-2016 |
|---|---|
| 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 | 2016-01-25 |
| Classified | 2016-02-22 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 78 |
| Reason classes | labeling |
| Lot numbers | 5341918 |
| Model numbers | 340918, 430918, FMC7 |
Product
BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
Reason for recall
Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label.
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-0851-2016. 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.