Device product
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.
Z-0968-2018
Product summary
- Event
- Event 79041
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,494,000
- Official record key
device-enforcement:Z-0968-2018
Official wording
Reason: 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.
Code information: Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.