Food, drugs, devices › Becton, Dickinson and Company, BD Biosciences
Device recall: CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in
Becton, Dickinson and Company, BD Biosciences (San Jose, CA) initiated this device recall on 27 Aug 2015; FDA lists 1 product record under event 72071, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 9 Aug 2016. Initiation: voluntary: firm initiated. Becton, Dickinson and Company, BD Biosciences has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Becton, Dickinson and Company, BD Biosciences, San Jose, CA.
Reason for recall
"CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC."
Distribution
"Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2817-2015 | CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on… | 128 units | Class III | Terminated | 30 Sep 2015 |
Context
Other enforcement events for Becton, Dickinson and Company, BD Biosciences
All 22 events for Becton, Dickinson and Company, BD Biosciences
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.