Recall Z-2154-2012— Greiner Bio-One North America, Inc.

Name: FDA recall Z-2154-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-02

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2012-07-02, terminated 2013-06-11. It names one FDA 510(k) clearance: K971221. Product: 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.. Reason: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Terminated: 2013-06-11
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K971221 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·cleared 1997-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

Data sourced from openFDA. This site is unofficial and independent of the FDA.