CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

Vacuette Tube 9NC Coagulation Sodium Citrate recalled

Greiner Bio-One North America is recalling Vacuette Tube 9NC Coagulation Sodium Citrate 3.2%, distributed nationwide in the US. The recall was initiated on 12 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.

Quantity recalled1,000,800 units.

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-1714-2020
FDA event ID: 85215
Recalling firm: Greiner Bio-One North America, Monroe, NC
Classification: Class II
Status: Terminated
Recall initiated: 12 Mar 2020
FDA classified: 15 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Mar 2020	Recall initiated by company
15 Apr 2020	Classified by FDA	+34 days
22 Apr 2020	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

Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

Product as listed by the FDA

VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

Where it was distributed

US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.

Nationwide Arkansas California Colorado Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan North Carolina Nebraska New Jersey New York Ohio Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

Which lots are affected?

Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.

Where was it sold?

US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.

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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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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