BD Microtainer Tube w/ BD Microgard Closure — Class II medical device recall Z-1967-2019
Terminated recall by Becton Dickinson & Company, reported 2019-07-24, distributed in AL, CA, CT, FL, GA, IL, KY, MD…. The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may devel
| Recall number | Z-1967-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2019-06-03 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-12-08 |
| Distributed | AL, CA, CT, FL, GA, IL, KY, MD, MN, MO, OH, PA, PR, TN, TX, VA |
| Quantity | 1,707,804 |
| Lot numbers | 9017588, 9017590, 9017591, 9017592, 9017593, 9017596, 9017600, 9028803, 9045873, 9046822, 9050660, 9052823, 9056896 |
| Model numbers | 365974, 365975 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.