FDA Recall Terminated

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: Z-3027-2020 · Initiated August 28, 2020

Recall

Recall Number
Z-3027-2020
Event Number
86363
Firm
Greiner Bio-One North America, Inc.
FEI Number
3001451379
Product Code
JKA
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
August 28, 2020
Terminated
June 17, 2021
Address
4238 Capital Dr, Monroe, NC, 28110-7681

Description

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.

Reason

Blood collection tubes experienced an issue with separation and clotting

Action

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 [email protected]. 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.

Distribution

US Nationwide distribution including in the states of IL, PA, VA, MO, NY.

Quantity

1,008,000 pieces