Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Gr
Summary
The FDA issued a Class II for Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog by Greiner Bio-One North America, Inc.. Reason: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassi.
Details
Source
Device Recall
External ID
Z-0200-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
Quantity Affected: 860450
Reason for Recall
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.
Distribution
U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Monroe, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Greiner Bio-One North America, Inc. has 8 FDA actions in our database, including 7 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Greiner Bio-One North America, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Greiner Bio-One North America, Inc. have FDA actions?
Greiner Bio-One North America, Inc. has 8 FDA actions in our database, including 7 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0200-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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