CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report

Greiner Bio-one Vacuette 9NC Coagulation sodium citrate recalled

Greiner Bio-One North America is recalling Greiner Bio-one Vacuette 9NC Coagulation sodium citrate 3.2%, distributed nationwide in the US. The recall was initiated on 8 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026

Quantity recalled504,000

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-0408-2026
FDA event ID: 97457
Recalling firm: Greiner Bio-One North America, Monroe, NC
Classification: Class II
Status: Ongoing
Recall initiated: 8 Aug 2025
FDA classified: 28 Oct 2025
Reported: 5 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Aug 2025	Recall initiated by company
28 Oct 2025	Classified by FDA	+81 days
5 Nov 2025	Published in enforcement report	+8 days

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

Reason for recall

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

Product as listed by the FDA

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026

Where was it sold?

US Nationwide distribution.

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 26 Sep 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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Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Device	CLASS II	Vacuette CAT Serum Separator Clot Activator recalled	Greiner Bio-One North America	Potency & Assay	28 states
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
26 Jan 2022Device	CLASS II	greiner bio-one Vacuette Tube LH Lithium Heparin Sep recalled	Greiner Bio-One North America	Other	10 states

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