Blood collection tubes recalled for missing additive and separation failures
Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.
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: FDA Class II recall affecting medical device functionality. No reported illnesses or injuries. The missing additive renders tubes unusable, requiring sample recollection and potentially delaying treatment, justifying the High severity despite no actual patient harm reported to date.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE blood collection tubes due to a manufacturing defect affecting clotting and separation performance.
Some units in the affected lot lack the necessary additive, causing poor clotting and separation of blood samples. These defective tubes are unusable and would require sample recollection, which could delay patient treatment.
The recalled product is VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator (item 455071P, lot B24013MV). Approximately 1,008,000 units in 840 cartons were distributed nationwide to all states.
Affected healthcare providers and laboratories should verify their inventory for the recalled lot number and quarantine any affected tubes. Contact Greiner Bio-One North America or your supplier for return procedures and replacement stock. Do not use affected tubes for blood collection.
The recalled product
- Product
- VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
- Manufacturer
- Greiner Bio-One North America, Inc.
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)
- Item Number: 455071P
- UDI Case label: 39120017573068
- UDI Rack label: 29120017573061
- Lot Number: B24013MV
Distribution
Related recalls
Same manufacturer · Greiner Bio-One North America, Inc.
See all →- SevereGreiner VACUETTE Blood Collection Tubes Recalled for EDTA Contamination
FDA (Devices) · 2026-10-28
- 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
- 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 · missing additive
See all →- HighBD Vacutainer Fluoride Tubes Recalled Due to Missing Preservative Additive
FDA (Devices) · 2019-08-21
Similar recalls
- ModerateGreiner Bio-One Recalls VACUETTE Blood Collection Tubes Due to Separation Issues
FDA (Devices) · 2020-10-07
- HighBlood tubes recalled after being manufactured without the gel separator
FDA (Devices) · 2025-11-26
- ModerateGreiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes
FDA (Devices) · 2020-01-29
- HighVACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive
FDA (Devices) · 2024-01-24
- HighGreiner Bio-One Recalls VACUETTE Blood Collection Tubes for Insufficient Draw Volume
FDA (Devices) · 2021-05-12
- HighGreiner VACUETTE 2 ml Coagulation Blood Collection Tubes Anticoagulant and Vacuum Recall
FDA (Devices) · 2021-09-29