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Recall Observatory FDA recall evidence

Device 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.

Z-1967-2019

June 03, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 83052
Status
Terminated
Classification
Class II
Quantity
1707804
Official record key
device-enforcement:Z-1967-2019

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.