Z-1967-2019Class II

BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975

Name: Z-1967-2019 BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975
Creator: Becton Dickinson & Company
Published: 2019-06-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-06-03 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer Brand Tube with EDTA(K2) Reorder... on 2019-06-03. FDA classified it as Class II and gives the reason as "The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1967-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-03
Posted: 2019-07-12
Terminated: 2020-12-08
Recalling firm: Becton Dickinson & Co
Product: BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC ,HGB, HCT, MCV, MCH, MCHC, Platelets, 5 part differential including : Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Manual WBC Differentials, Reticulocytes, and Spun Hematocrit.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 6/3/19 were sent to customers. Thee letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 1707804
Distribution: The products were distributed to the following US states: AL, CA, CT, FL, GA, IL, KY, MD, MN, MO, OH, PA, TN, TX, VA, and Puerto Rico.
Product codes and lots: Lot Numbers: 9017588 9017590 9017591 9017592 9017593 9017596 9017600 9028803 9045873 9046822 9050660 9052823 9056896

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1967-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1967-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-12

Product code JKA

K931368Class IIMicrotainer Brand Tube with EdtaBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1993-09-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)