Greiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes
Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (vacuum loss) that may affect sample volume but does not present an immediate risk of serious injury or death.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling 1,002,000 units of VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P. The affected product is identified by DI 29120049204476 and Lot number B190338E. These tubes are used in clinical laboratories to collect, transport, and process venous blood for testing serum, plasma, or whole blood.
The recall was initiated because the tubes may have been damaged at the cap sealing area. This damage may lead to a loss of vacuum, resulting in the tubes not filling up to the proper volume. The agency has classified this recall as Class II.
The affected products were distributed nationwide in the states of Illinois, Missouri, Arizona, North Carolina, Pennsylvania, Utah, New York, Maine, Puerto Rico, and Virginia. Healthcare facilities and laboratories should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or who
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 1,002,000
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 (2)
- DI: 29120049204476
- Lot number B190338E
Distribution
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