Recall Z-2252-2016 ยท GKZ Counter, Differential Cell
Becton, Dickinson and Company, BD Biosciences
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
| Date | Jun 24, 2016 |
| Status | Terminated |
| Reason | One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product. |
| Root cause | Packaging process control |
| Action | Urgent Product Correction notifications letters were sent on June 24, 2016 to all affected customers. Letters identify the issue and product and provide illustrations of the Kit Box and pouch labels. Correction letters identified the issue and the product involved with photos of product labels. BD letters states that they want to reinforce the need to visually inspect the desiccant contained in each pouch . If the desiccant has turned from blue to lavender, discard the remaining tubes. The acknowledgement form should be completed and returned regardless if any inventory remains. If you |
| Quantity | 328 US, 516 International |
| Distribution | USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile |
| 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 |