Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17921 |
| Brand Name: | BD CD8 Phycoerythrin (PE) |
| Model: | 340046 |
| Affected: | 4220622 |
| Software version: | |
| Recalling Organisation: | Becton Dickinson Ltd Unit 4 / 110 Mays Road Onehunga Auckland 1061 |
| Contact Information: | 0800 572 468 |
| Manufacturer: | |
| Issue: | It has been identified that the CD8 PE reagent has been contaminated with a low amount of CD4 FITC. It has been confirmed that the concentration of the CD8 antibody in the OE conjugate is sufficient to detect CD8 antigen on the targeted cells however the presence of CD4 could result in the possibility of an unexpected staining pattern. The concern with the above issue is that the CD4 cells will be expressed along the FITC axis. Any marker that is stained on the FITC axis will contain this incorrectly stained CD4 population. Subsequent downgating will make the data appear as if the CD4 population is not present. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/12/2014 |
