Recall Z-2378-2016— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-2378-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-18

Class III · Terminated

Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2016-07-18, terminated 2017-03-01. It names one FDA 510(k) clearance: K071143. Product: BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.. Reason: Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class III
Status: Terminated
Initiated: 2016-07-18
Terminated: 2017-03-01
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071143 — BD TRITEST CD3/CD4/CD45, MODEL 340383Bd Biosciences·cleared 2007-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.

Reason for recall

Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.