Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc
Summary
The FDA issued a Class II for Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Mod by Greiner Bio-One North America, Inc.. Reason: Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and .
Details
Source
Device Recall
External ID
Z-0571-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N UDI-DI code: 29120017573061
Quantity Affected: 1,980,000
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-19
Company
Monroe, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Greiner Bio-One North America, Inc. has 9 FDA actions in our database, including 8 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Greiner Bio-One North America, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Greiner Bio-One North America, Inc. have FDA actions?
Greiner Bio-One North America, Inc. has 9 FDA actions in our database, including 8 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0571-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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