FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2252-2016
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Product
- BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
- Status
- Terminated
- Initiated
- 2016-06-24
- Posted
- not on file
- Terminated
- 2016-12-02
- 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 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
- 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
- Lot, serial or model codes
- Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)
- 510(k) numbers
- ["K970836"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28