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.
FDA Recall Z-3027-2020 · Posted None
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Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2020-08-28
Date Terminated2021-06-17
Product Quantity1,008,000 pieces
Reason for Recall
Blood collection tubes experienced an issue with
separation and clotting
Firm 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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including in the states of IL, PA, VA, MO, NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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