Food, drugs, devices › Greiner Bio-One North America, Inc.

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

FDA enforcement event 85215 · Class II · initiated 12 Mar 2020 · status Terminated · terminated 31 Aug 2022

DeviceVoluntary: Firm initiated1 product recordMonroe, NC

Greiner Bio-One North America, Inc. (Monroe, NC) initiated this device recall on 12 Mar 2020; FDA lists 1 product record under event 85215, classified Class II.

FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 31 Aug 2022. Initiation: voluntary: firm initiated. Greiner Bio-One North America, Inc. has 16 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

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

Reason for recall

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

Distribution

"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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1714-2020	VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.	1,000,800 units.	Class II	Terminated	22 Apr 2020

Context

93%of 2020 device events are Class II916 events that year

1product record in this eventfirm median: 1

16events on this register for the firm

Other enforcement events for 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-ri	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

All 16 events for Greiner Bio-One North America, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 31 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.