Z-0968-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- August 29, 2017
- Termination Date
- May 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,494,000
Product Description
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Reason for Recall
A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
Distribution Pattern
Nationwide Distribution
Code Information
Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410