FDA-Device2026-10-21Class IIPROCESSING DEFECT

Greiner VACUETTE lithium heparin blood collection tubes recalled for EDTA contamination risk

OTHERNationwide distributionMedical devices

What this means

Certain Greiner VACUETTE blood collection tubes (lot B26043FM) may be contaminated with EDTA, a chemical that can interfere with test results. This contamination can cause lab tests to show falsely high potassium and falsely low calcium levels, which could lead to serious medical decisions based on incorrect results.

Check if your facility received tubes from lot B26043FM (expiration date July 12, 2027).
Do not use affected tubes; quarantine and return them to Greiner Bio-One.
Contact your lab supplier or Greiner Bio-One if you have questions about which lots you received.

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The agency's original wording

Hazard

Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.

Intended for

All ages

Illnesses reported

None reported

Sold states

U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.

Affected count

860450

Manufactured in

4238 Capital Dr, Monroe, North Carolina, United States

Products

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)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2027

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