Z-3027-2020 Class II Terminated
FDA device recall Z-3027-2020 was initiated by Greiner Bio-One North America, Inc. on August 28, 2020 and is designated Class II. Reason for recall: Blood collection tubes experienced an issue with separation and clotting The recall status is terminated (terminated June 17, 2021). Affected quantity: 1,008,000 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- August 28, 2020
- Termination Date
- June 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,008,000 pieces
Product 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 for Recall
Blood collection tubes experienced an issue with separation and clotting
Distribution Pattern
US Nationwide distribution including in the states of IL, PA, VA, MO, NY.
Code Information
Lot Number: B2003399