FDA-Device2012-08-15Class II
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Greiner Bio-One North America, Inc.
Hazard
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Sold states
Nationwide Distribution
Affected count
838.9 cases (1,006,700 pieces)
Manufactured in
4238 Capital Dr, Monroe, NC, United States
Products
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2154-2012Don't want to check this manually?
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