Skip to content
Recall Observatory FDA recall evidence

Device product

VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

Z-1534-2021

March 29, 2021

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 87660
Status
Terminated
Classification
Class II
Quantity
1,049,700 units
Official record key
device-enforcement:Z-1534-2021

Official wording

Reason: VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

Code information: Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022 Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022 Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022 Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022

Distribution pattern: US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.