Z-1570-2016Class II

BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining...

Name: Z-1570-2016 BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2016-03-31
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2016-03-31 / Terminated / root cause: packaging

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount... on 2016-03-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1570-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Posted: 2016-04-26
Terminated: 2017-05-26
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.
Product code: GKZ Counter, Differential Cell
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Model: 340334; Manufacaturing lot: 534964

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1570-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1570-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-26

Product code GKZ

K970836Class IITrucount Absolute Count Tubes/counting Control BeadsBecton Dickinson Immunocytometry Systems / cleared 1997-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)