Z-0571-2026Class II

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P...

Name: Z-0571-2026 Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P...
Creator: Greiner Bio-One North America, Inc.
Published: 2025-08-19
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2025-08-19 / Open, Classified / root cause: labeling and UDI

FDA source

Greiner Bio-One North America, Inc. began a recall of Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection... on 2025-08-19. FDA classified it as Class II and gives the reason as "Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat...". 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-0571-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-19
Posted: 2025-11-19
Recalling firm: Greiner Bio-One North America, Inc.
Product: Brand 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)
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 08/22/2025, the firm sent via email an "Urgent Medical Device Correction" letter to customer informing them that some Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator which may affect the stability of the sample. Customers are instructed to: " Stop use immediately: Discontinue use of the affected product (concerned Item/Lot) and isolate it within your facility. " Notify staff and customers: Inform all relevant employees and notify all customers to whom you distributed the affected products. " Assess risk: Evaluate potential risks or consequences in accordance with your internal procedures and take appropriate action. " Confirm product disposition: Complete the attached Product Disposition Site Confirmation Form and return it via fax to 877-217-7927 or email to [email protected]. Confirmation is required that all affected products have been discarded/destroyed. Replacement products will be provided upon receipt of your completed form. For questions, call Greiner Bio-One Technical Service at 800-515-8112.
Quantity in commerce: 1,980,000
Distribution: U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: None
Product codes and lots: Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0571-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0571-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-19

Product code JKA

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)