Z-2252-2016Class II

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute...

Name: Z-2252-2016 BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2016-06-24
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2016-06-24 / Terminated / root cause: packaging

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood on 2016-06-24. FDA classified it as Class II and gives the reason as "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". 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-2252-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-24
Posted: 2016-07-21
Terminated: 2016-12-02
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.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: packaging
FDA 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 in commerce: 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
Product codes and lots: Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-21

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)