Recall Register

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Greiner Bio-One North America, Inc.

FDA recalling firm · 16 enforcement events · 16 product records · 2012–2025 · NC

Greiner Bio-One North America, Inc. has 16 FDA enforcement events on this register (16 product records) between 2012 and 2025: 16 device; the busiest year was 2021 with 4.

0% of its events are Class I; the most common class is Class II (16). 4 events are listed as ongoing; the recalling firm's address is in NC.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
19 Aug 2025Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)DeviceClass II1Ongoing
8 Aug 2025Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322DeviceClass II1Ongoing
14 May 2024VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridgedDeviceClass II1Ongoing
12 Dec 2023VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.DeviceClass II1Ongoing
31 Mar 2023greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003DeviceClass II1Completed
9 Dec 2021greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087PDeviceClass II1Terminated
20 Aug 2021Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridgedDeviceClass II1Terminated
13 Aug 2021VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridgedDeviceClass II1Terminated
29 Mar 2021VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.DeviceClass II1Terminated
28 Aug 2020VACUETTE 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.DeviceClass II1Terminated
12 Mar 2020VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.DeviceClass II1Terminated
25 Nov 2019VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.DeviceClass II1Terminated
26 Apr 20164 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactateDeviceClass II1Terminated
1 Feb 2013VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.DeviceClass II1Terminated
2 Jul 20123mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.DeviceClass II1Terminated
2 Apr 2012Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel…DeviceClass II1Terminated

By type and class

Device16
Class II16

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Greiner Bio-One North America, Inc. by year initiated.

Questions and answers

How many FDA recalls has Greiner Bio-One North America, Inc. had?

16 enforcement events (16 product records) on this register, 2012–2025: 16 device.

Are any Greiner Bio-One North America, Inc. recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Greiner Bio-One North America, Inc. recalls?

16 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.