Recall Z-1967-2019 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
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,
| Date | Jun 3, 2019 |
| Status | Terminated |
| Reason | 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931368 | MICROTAINER BRAND TUBE WITH EDTA Bd Becton Dickinson Vacutainer Systems Preanalytic, Sep 28, 1993 |