Device recall: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description…

Class II FDA enforcement event 99518. Recall start date: 29 Jul 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

Greiner Bio-One North America, Inc. started this device recall on 29 Jul 2026. The firm address in the FDA record is in Monroe, NC. FDA put the recall in Class II. FDA event 99518 has 1 product record. The first FDA enforcement report date is 28 Oct 2026. The record gives the status Ongoing. 286 of the 697 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 3 Nov 2026.

Distribution

In the words of FDA.

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

Recalling firm

Greiner Bio-One North America, Inc., Monroe, NC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 99518: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0200-2027	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)	860450	Class II	Ongoing	28 Oct 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 697
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 17

Other events of the firm

Other FDA enforcement events of Greiner Bio-One North America, Inc.
Initiated	Product (first record)	Type	Class	Records
19 Aug 2025	Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Descrip	Device	Class II	1
8 Aug 2025	Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322	Device	Class II	1
14 May 2024	VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged	Device	Class II	1
12 Dec 2023	VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.	Device	Class II	1
31 Mar 2023	greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in	Device	Class II	1
9 Dec 2021	greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs	Device	Class II	1
20 Aug 2021	Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-rid	Device	Class II	1
13 Aug 2021	VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged	Device	Class II	1
29 Mar 2021	VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged	Device	Class II	1
28 Aug 2020	VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transp	Device	Class II	1

Greiner Bio-One North America, Inc.: all 17 events

Official channels

FDA enforcement report Z-0200-2027The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 99518. https://recallregister.com/fda/ii/99518/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
Newest FDA report date on the register: 28 Oct 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
What quantity of product is in FDA event 99518?: The FDA record gives this quantity: 860450
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 697 device events that started in 2026 are in Class II.