Z-0628-2016Class III

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent

Name: Z-0628-2016 FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2015-12-14
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-12-14 / Terminated

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent on 2015-12-14. FDA classified it as Class III and gives the reason as "Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0628-2016
Classification: Class III
Status: Terminated
Initiated: 2015-12-14
Posted: 2016-01-11
Terminated: 2016-10-31
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.
FDA root cause: Under Investigation by firm
Action: BD Biosciences sent an Urgent Product Recall letter dated December 2015, to all affected customers to inform them that Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return the Tracking/Verification form to BD Biosciences. Customers are instructed to contact BD Customer Support at (877) 232-8995 (prompt 3, 3) in the US. Customers outside of the US are instructed to contact their local BD Biosciences or distributor.
Quantity in commerce: 1,388 units
Distribution: Nationwide Distribution
Product codes and lots: Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0628-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0628-2016	Class III	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-11

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)