—#173416

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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K931368
Affected lot / code info: Lot Numbers: 9017588 9017590 9017591 9017592 9017593 9017596 9017600 9028803 9045873 9046822 9050660 9052823 9056896

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-06-03
Terminated: 2020-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.