Recall Z-1570-2016 ยท GKZ Counter, Differential Cell
Becton, Dickinson and Company, BD Biosciences
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
| Date | Mar 31, 2016 |
| Status | Terminated |
| Reason | One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used. |
| Root cause | Packaging |
| Action | BD Biosciences sent an Urgent Product Recall letter dated March 2016 to all affected customers on March 31, 2016 by Certified Mail, e-mail and direct delivery by Sales Associates. Letters instructed that any remaining inventory of the affected lot be discarded and that date files obtained using reagents from the affected lot be reviewed for the possibility of incorrect data. Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt3, 3) in the united State. For customers outside the US, customers should contact their local BD Biosciences representative or |
| Quantity | 1743; 467 US and 1276 International |
| Distribution | Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970836 | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS Becton Dickinson Immunocytometry Systems, Aug 26, 1997 |