device · product 1 of 1
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.
- Recall number
- Z-1967-2019
- Initiated
- June 03, 2019
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 1707804
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
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.
Code information
Lot Numbers: 9017588 9017590 9017591 9017592 9017593 9017596 9017600 9028803 9045873 9046822 9050660 9052823 9056896
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.