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Recall Observatory FDA recall evidence

Device product

VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

Z-1714-2020

March 12, 2020

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 85215
Status
Terminated
Classification
Class II
Quantity
1,000,800 units.
Official record key
device-enforcement:Z-1714-2020

Official wording

Reason: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

Code information: Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.

Distribution pattern: US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.