CLASS II Device recall · Reported 7 Oct 2020 · FDA Enforcement Report

Vacuette Tube Cat Serum Separator Clot Activator recalled

Greiner Bio-One North America is recalling Vacuette Tube Cat Serum Separator Clot Activator, distributed nationwide in the US. The recall was initiated on 28 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: B2003399

Quantity recalled1,008,000 pieces

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-3027-2020
FDA event ID: 86363
Recalling firm: Greiner Bio-One North America, Monroe, NC
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2020
FDA classified: 29 Sep 2020
Reported: 7 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Aug 2020	Recall initiated by company
29 Sep 2020	Classified by FDA	+32 days
7 Oct 2020	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 experienced an issue with separation and clotting

Product as listed by the FDA

VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.

Where it was distributed

US Nationwide distribution including in the states of IL, PA, VA, MO, NY.

Nationwide Illinois Missouri New York Pennsylvania Virginia

Questions about this recall

Why was it recalled?

Blood collection tubes experienced an issue with separation and clotting

Which lots are affected?

Lot Number: B2003399

Where was it sold?

US Nationwide distribution including in the states of IL, PA, VA, MO, NY.

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

All 16

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
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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