FDA recall, , Moderate risk
VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator
Blood collection tubes may contain EDTA contamination, leading to falsely elevated potassium and decreased calcium results.
Summary by Recall Canary from the FDA notice
What happened
Greiner Bio-One North America, Inc. recalled its VACUETTE LH Lithium Heparin Separator blood collection tubes, model 454008P, because the product may include EDTA contamination. This contamination introduces potassium while chelating calcium in patient samples, potentially causing falsely elevated potassium and falsely decreased calcium results, which could lead to hyperkalemia.
The recall began on July 29, 2026, and was added to the FDA's Enforcement Report on October 21, 2026. The affected tubes were distributed in Colorado, Florida, Illinois, Missouri, Nebraska, New York, Ohio, Pennsylvania, and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your tube affected?
Match the lot code, UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator
- Lot code
- B26043FM
VACUETTE LH Lithium Heparin Separator
- UDI-DI
- 29120017579032
- 39120017579039
- Model/Catalog number
- 454008P
- Lot code
- B26043FM
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Colorado, Florida, Illinois, Missouri, Nebraska, New York, Ohio, Pennsylvania, and Virginia.
- Company
- Greiner Bio-One North America, Inc.
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99518
- Recall number
- Z-0200-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
