Z-1967-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- June 3, 2019
- Termination Date
- December 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1707804
Product Description
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.
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.
Code Information
Lot Numbers: 9017588 9017590 9017591 9017592 9017593 9017596 9017600 9028803 9045873 9046822 9050660 9052823 9056896