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.
Check against the official notice below — it lists the full affected range.
Greiner Bio-One North America, Inc. is recalling VACUETTE Blood Collection tubes (9NC Coagulation sodium citrate 3.2%, 13x75 blue cap-white ring, sandwich tube, non-ridged) because the tubes may contain insufficient draw volume. This condition could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays. Approximately 1,049,700 units were distributed nationwide across 18 states including Kentucky, Texas, Louisiana, Ohio, Arkansas, Illinois, South Carolina, Pennsylvania, Florida, North Carolina, Arizona, California, Michigan, Nebraska, Kansas, Missouri, New York, and New Jersey.
The recalled tubes include four specific lots with expiration dates ranging from February 1, 2022 to March 1, 2022, identified by item numbers 454322, 454332, and 454334, and their corresponding lot numbers and UDI codes. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ. Quantity: 1,049,700 units Lot/code info: Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022 Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022 Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022 Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.