CLASS II Device recall · Reported 12 May 2021 · FDA Enforcement Report

Vacuette¿ Blood Collection tube 9NC Coagulation sodium recalled

Greiner Bio-One North America is recalling Vacuette¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% blue cap-white ring, distributed nationwide in the US. The recall was initiated on 29 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022 Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022 Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022 Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022

Quantity recalled1,049,700 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-1534-2021
FDA event ID: 87660
Recalling firm: Greiner Bio-One North America, Monroe, NC
Classification: Class II
Status: Terminated
Recall initiated: 29 Mar 2021
FDA classified: 6 May 2021
Reported: 12 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Syringes & Needles

Timeline

29 Mar 2021	Recall initiated by company
6 May 2021	Classified by FDA	+38 days
12 May 2021	Published in enforcement report	+6 days

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

Reason for recall

VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

VACUETTE¿ 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.

Where it was distributed

US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.

Nationwide Arkansas Arizona California Florida Illinois Kansas Kentucky Louisiana Michigan Missouri North Carolina Nebraska New Jersey New York Ohio Pennsylvania South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022 Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022 Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022 Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022

Where was it sold?

US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.

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

Other Syringes & Needles recalls

All 1,060

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL