CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report

Vacuette LH Lithium Heparin Separator recalled

Greiner Bio-One North America is recalling Vacuette LH Lithium Heparin Separator, distributed nationwide in the US. The recall was initiated on 29 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12

Quantity recalled860450

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0200-2027
FDA event ID: 99518
Recalling firm: Greiner Bio-One North America, Monroe, NC
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jul 2026
FDA classified: 21 Oct 2026
Reported: 28 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

29 Jul 2026	Recall initiated by company
21 Oct 2026	Classified by FDA	+84 days
28 Oct 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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)

Where it was distributed

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

Nationwide Colorado Florida Illinois Missouri Nebraska New York Ohio Pennsylvania Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Greiner Bio-One North America

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26 Nov 2025Device	CLASS II	Vacuette CAT Serum Separator Clot Activator recalled	Greiner Bio-One North America	Potency & Assay	28 states
5 Nov 2025Device	CLASS II	Greiner Bio-one Vacuette 9NC Coagulation sodium citrate recalled	Greiner Bio-One North America	Other	Nationwide
24 Jul 2024Device	CLASS II	Vacuette¿ Tube Cat Serum Separator Clot Activator red recalled	Greiner Bio-One North America	Device Malfunction	Nationwide
24 Jan 2024Device	CLASS II	Vacuette Tube FX Sodium Fluoride/Potassium Oxalate recalled	Greiner Bio-One North America	Other	Nationwide
24 May 2023Device	CLASS II	greiner bio-one Vacuette Tube K3E K3EDTA recalled	Greiner Bio-One North America	Labeling Errors	Nationwide

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