ClearanceBrief
Recall Z-0447-03 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Becton Dickinson & Company

Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.

DateJan 16, 2003 (initiated Oct 16, 2002)
StatusTerminated
ReasonInsufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
Root causeOther
ActionBecton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
Quantity141600
DistributionThe firm distributed this product nationwide to wholesalers and direct customers.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K940905MICROTAINER BRAND TUBE WITH EDTA(K2)
Bd Becton Dickinson Vacutainer Systems Preanalytic, Aug 2, 1994