Greiner VACUETTE Blood Collection Tubes Recalled for EDTA Contamination
Greiner Bio-One is recalling specific VACUETTE blood collection tubes due to EDTA contamination that may cause falsely elevated potassium and decreased calcium 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II by the FDA. The source identifies a hazard where EDTA contamination leads to falsely elevated potassium and decreased calcium results, which have the potential to cause hyperkalemia. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling specific lots of VACUETTE LH Lithium Heparin Separator blood collection tubes. The affected product is identified by Item Number 454008P and Lot Number B26043FM. These tubes are 13 x 75 mm, 3.5ml blood collection tubes with lithium heparin and a gel separator.
The recall is being issued because the lot may include EDTA contamination. This contamination introduces potassium while chelating calcium in patient samples, which can lead to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results. These inaccurate results have the potential to cause hyperkalemia.
The affected units were distributed nationwide in the states of Colorado, Florida, Illinois, Missouri, Nebraska, New York, Ohio, Pennsylvania, and Virginia. The expiration date for the affected lot is July 12, 2027. Healthcare facilities and laboratories should stop using the affected tubes and contact the manufacturer for further instructions.
The recalled product
- Product
- Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 860,450
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)
- Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032
- Case: 39120017579039 Expiration Date: 2027-07-12
Distribution
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