Recall Z-1534-2021— Greiner Bio-One North America, Inc.

Name: FDA recall Z-1534-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-29

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2021-03-29, terminated 2023-10-10. It names one FDA 510(k) clearance: K971221. 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.. 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..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Terminated: 2023-10-10
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

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.

Reason for recall

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.

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