Greiner VACUETTE 2 ml Coagulation Blood Collection Tubes Anticoagulant and Vacuum Recall
Greiner Bio-One is recalling 956,400 VACUETTE coagulation blood collection tubes that may clot due to anticoagulant variation or low vacuum.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where no injury has been reported. The anticoagulant variation and low vacuum could compromise blood sample integrity, but the source documents only complaints, not confirmed illnesses or injuries.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2% blood collection tubes with blue cap-white ring due to a potential anticoagulation defect. The recall affects 956,400 units.
The company received complaints that some tubes may clot due to variation in the anticoagulant content and/or low vacuum in the tubes. This defect could compromise the quality and validity of blood samples collected using these tubes.
The affected tubes were distributed nationwide across 25 states and Puerto Rico (AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA). Two lot numbers are affected: B210533B (Expiration 05/10/22) and B210439J (Expiration 04/13/2022).
Healthcare facilities and clinical laboratories should stop using the recalled tubes and not distribute them. Contact Greiner Bio-One North America for return and replacement instructions.
The recalled product
- Product
- Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 956,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.
Distribution
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