BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
- Recall Initiated
- June 24, 2016
- Terminated
- December 2, 2016
- Recall Number
- Z-2252-2016
- Quantity
- 328 US, 516 International
- Firm Location
- San Jose, CA
Reason for Recall
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.
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
Lot / Code Info
Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)
Root Cause
Packaging process control
Action Taken
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 require further assistance, please contact BD Customer Support at 855.236.2772 (prompt 3) in the Unites States. For customers outside the US, contact your local BD Biosciences representative or distributor