Z-0408-2026Class II

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Name: Z-0408-2026 Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Creator: Greiner Bio-One North America, Inc.
Published: 2025-08-08
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2025-08-08 / Open, Classified / root cause: labeling and UDI

FDA source

Greiner Bio-One North America, Inc. began a recall of Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 on 2025-08-08. FDA classified it as Class II and gives the reason as "Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0408-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-08
Posted: 2025-10-28
Recalling firm: Greiner Bio-One North America, Inc.
Product: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
Reason for recall: Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Greiner issued an Urgent Product Recall notice to its consignees on 08/19/2025 via email and fax. The notice explained the issue and requested the following: "Immediate Actions Required 1. Stop Distribution & Isolate Inventory Immediately cease distribution of the affected lot and segregate all remaining units. 2. Select ONE of the following notification options: A. Customer Notification by Greiner Bio-One o Complete the attached Product Disposition Site Confirmation form. o Email the form to [email protected] or fax to 877-217-7927. o Provide an Excel list of all customers including, if applicable, subdistributors who received the affected product, containing: . Facility name and address (city, state, ZIP) . Contact name, email, and phone number for Clinical/Laboratory Director or Supply Chain . Date(s) and quantity shipped o Greiner will handle direct customer notification and coordinate product return/credit. B. Customer Notification by Distributor o Use the customer letter provided by Greiner Bio-One. o Contact all customers who received the affected lot, including any sub-distributors. o Conduct follow-up with non-responders and document effectiveness checks per FDA guidance: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industryguidance-recalls" For questions regarding this recall, please contact: Greiner Bio-One Technical Service, Phone: 800-515-8112, Fax: 877-217-7927, Email: [email protected]
Quantity in commerce: 504,000
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0408-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-28

Product code GIM

K971221Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)