Recall Z-0851-2016— Becton, Dickinson and Company, BD Biosciences
Class III · Terminated
Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2016-01-25, terminated 2016-10-18. FDA's recall record names no specific 510(k) clearance for this event. 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: Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-01-25
- Terminated
- 2016-10-18
- Firm location
- San Jose, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.