Z-0851-2016Class III

BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells...

Name: Z-0851-2016 BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2016-01-25
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2016-01-25 / Terminated / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte... on 2016-01-25. FDA classified it as Class III and gives the reason as "Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0851-2016
Classification: Class III
Status: Terminated
Initiated: 2016-01-25
Posted: 2016-02-23
Terminated: 2016-10-18
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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.
Product code: MVU Reagents, Specific, Analyte
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: BD Biosciences sent an Urgent Medical Device Recall letters dated January 2016 via certified mail to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that the remaining stock of the product can be used until 6-30-16. however, if prefer they can discard all remaining stock of the affected lot and BD will replace. The letter request customers complete the Tracking/verification form and returned to BD Biosciences, per the instructions (mail, fax, or email). For questions contact your local BD representative or BD Customer Support at 877-232-8995 (prompt 3,3).
Quantity in commerce: 78
Distribution: Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.
Product codes and lots: Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0851-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0851-2016	Class III	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)