Device Recall BD Vacutainer PLUS K2EDTA Plus Blood Collection Tubes 의 리콜

Recall

72868

Class 2

Z-0570-2016

2015-12-03

2015-12-31

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142387

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.

The firm, BD, issued an "URGENT PRODUCT RECALL" notifications/Recall Response Forms to their customers dated 12/3/2015 via email and/or UPS 2nd Day Mail. The notification identified the reason for the recall; how to identify affected product; and actions to be taken. The customers were instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-866-873-0312 it to BD or email it to bd4964@stericycle.com; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction, even if you do not have any affected lot in your inventory. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-888-628-0732 between 8AM and 5 PM ET Monday through Friday.