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Recall Observatory FDA recall evidence

Device product

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.

Z-0567-2016

December 03, 2015

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 72868
Status
Terminated
Classification
Class II
Quantity
29,815,600 units in total
Official record key
device-enforcement:Z-0567-2016

Official wording

Reason: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.

Code information: Catalog Reference #367842; Lot numbers 5089731 and 5175923

Distribution pattern: Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.