Greiner Bio-One North America, Inc. VACUETTE 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VACUETTE 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.
Brand
Greiner Bio-One North America, Inc.
Lot Codes / Batch Numbers
Lot Number: B2003399
Products Sold
Lot Number: B2003399
Greiner Bio-One North America, Inc. is recalling VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are use due to Blood collection tubes experienced an issue with separation and clotting. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Blood collection tubes experienced an issue with separation and clotting
Recommended Action
Per FDA guidance
Greiner Bio-One North America issued an urgent product recall notification on August 28, 2020. It state the following: 1. Stop distributing the mentioned product (concerned item/lot) immediately and isolate defective products in your facility. 2. Complete the Product Disposition form and fax it to Greiner at 800.726.0052 or email to patech@gbo.com. 3. Greiner will contact you for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. Greiner will also use this information to send you replacement stock or issue a credit. 4. Please provide Greiner with a list of your customers that have received the item with this specific lot number. Include: Facility, Address, Key contact, Phone number, Fax, and Date shipped. Please provide this as an Excel file preferably. If this is not possible, please forward the information in any format. If you have additional questions, please call Greiner Technical Service at 800-515-8112.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026