FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1570-2016
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-03-31
- Posted
- not on file
- Terminated
- 2017-05-26
- 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 distributor. For questions regarding this recall call 408-954-6080.
- 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.
- Lot, serial or model codes
- Model: 340334; Manufacaturing lot: 534964
- 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