FDA-Device2020-04-22Class II

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

Greiner Bio-One North America, Inc.
Hazard

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

Sold states
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.
Affected count
1,000,800 units.
Manufactured in
4238 Capital Dr, Monroe, NC, United States
Products
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1714-2020

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