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.
Reported: May 12, 2021 Initiated: March 29, 2021 #Z-1534-2021
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.
Details
- Recalling Firm
- Greiner Bio-One North America, Inc.
- Units Affected
- 1,049,700 units
- 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.
- Location
- Monroe, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Greiner Bio-One North America, Inc.. Units affected: 1,049,700 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 12, 2021. Severity: Moderate. Recall number: Z-1534-2021.
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