Product Wiki · Recalls · Health Canada — Medical Devices

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes (2017-08-28) — recall 57484

Health Canada — Medical Devices · Canada · 2017-09-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57484
Date of alert
2017-09-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: BD has confirmed that 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-vacutainer-k2-edta-k2e-36mg

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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