Severity
Moderate
FDA Devices recall · Reported July 27, 2016
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.
Becton, Dickinson and Company, Bd Biosciences recalled BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used … - a moderate-severity action.
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used … was recalled by Becton, Dickinson and Company, Bd Biosciences in July 27, 2016. Reason: One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient envir…. Check the official notice for the remedy. Verify recall #Z-2252-2016 with the FDA Devices before acting.
The recall
Becton, Dickinson and Company, Bd Biosciences issued this moderate-severity FDA Devices recall-One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient envir….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2252-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2252-2016) was formally reported on July 27, 2016, with the manufacturer initiating the action on June 24, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton, Dickinson and Company, Bd Biosciences is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 328 US, 516 International.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
328 US, 516 International
Related Recalls
6
3 from same agency
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2252-2016 |
| Date reported | July 27, 2016 |
| Date initiated | June 24, 2016 |
| Recalling firm | Becton, Dickinson and Company, Bd Biosciences |
| Firm location | San Jose, CA |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 27, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.