Greiner Bio-One Recalls VACUETTE Blood Collection Tubes for Insufficient Draw Volume
Greiner Bio-One is recalling VACUETTE blood collection tubes because insufficient draw volume may cause erroneous coagulation test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves erroneous medical test results, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
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. The recall involves 1,049,700 units distributed nationwide in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MO, NY, and NJ.
The recall was initiated because the tubes may show insufficient draw volume. This issue could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays. The product is indicated for use in the collection and transport of venous whole blood for coagulation testing.
Healthcare facilities and consumers should stop using the affected lots immediately. Specific lot numbers and expiration dates are listed in the official recall notice. Users should contact the manufacturer for further instructions or to arrange for a replacement or refund.
The recalled product
- 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.
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 1,049,700
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 (12)
- 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
- Expiration Date: 02/13/2022
Distribution
Related recalls
Same manufacturer · Greiner Bio-One North America, Inc.
See all →- HighBlood tubes recalled after being manufactured without the gel separator
FDA (Devices) · 2025-11-26
- ModerateCoagulation blood tubes recalled over a misplaced label shifting the fill mark
FDA (Devices) · 2025-11-05
- HighBlood collection tubes recalled for missing additive and separation failures
FDA (Devices) · 2024-07-24
- HighVACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive
FDA (Devices) · 2024-01-24
- ModerateGreiner Bio-One Blood Collection Tubes Recalled for Labeling Error
FDA (Devices) · 2023-05-24
Same hazard · erroneous test results
See all →- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighVITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results
FDA (Devices) · 2025-07-09
- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing
FDA (Devices) · 2024-03-13
Similar recalls
- HighGreiner VACUETTE 2 ml Coagulation Blood Collection Tubes Anticoagulant and Vacuum Recall
FDA (Devices) · 2021-09-29
- ModerateGreiner Bio-One Recalls Coagulation Blood Collection Tubes Due to Concentration Error
FDA (Devices) · 2012-08-15
- ModerateGreiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency
FDA (Devices) · 2020-04-22
- ModerateCoagulation blood tubes recalled over a misplaced label shifting the fill mark
FDA (Devices) · 2025-11-05
- ModerateGreiner Bio-One Blood Collection Tubes Recalled for Labeling Error
FDA (Devices) · 2023-05-24
- ModerateBlood collection tubes recalled due to potential clotting defect
FDA (Devices) · 2021-10-06