Blood Collection Tubes Recalled Due to Lithium Heparin Variation
Greiner Bio-One is recalling 889,200 blood collection tubes (Lot #B21053QG) due to variation in lithium heparin that may cause blood clotting. The tubes were distributed to ten U.S. states.
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: FDA Class II recall with documented material defect (lithium heparin variation) affecting device function. No reported illnesses or injuries. The defect creates risk of diagnostic failure through unusable blood samples, qualifying this as a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE blood collection tubes (5 ml, lithium heparin separator, catalog reference 456087P). A total of 889,200 units from Lot #B21053QG are affected. These tubes were distributed to healthcare providers and laboratories in Florida, Illinois, Missouri, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas, and Virginia.
The affected tubes show clotting due to variation in lithium heparin anticoagulant. Lithium heparin is the chemical responsible for preventing blood clotting in the collection tube. When the heparin content varies, the tubes may fail to properly anticoagulate blood samples, resulting in unusable specimens for diagnostic testing.
The affected lot expires September 9, 2022. The FDA classified this as a Class II recall, indicating a medical device with a material defect. Entities using or possessing these tubes are advised to cease use and contact Greiner Bio-One North America, Inc. for replacement product and instructions.
The recalled product
- Product
- greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
- Manufacturer
- Greiner Bio-One North America, Inc.
- Hazard
- anticoagulation-failure
- manufacturing-variation
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 (4)
- Lot #B21053QG
- Exp. 09/09/2022
- UDI: Case: 39120017579046
- Rack: 29120017579049.
Distribution
Distributed in 10 states:
- FL
- IL
- MO
- NC
- NM
- NY
- PA
- TN
- TX
- VA
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