Device 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.
Z-3027-2020
Product summary
- Event
- Event 86363
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,008,000 pieces
- Official record key
device-enforcement:Z-3027-2020
Official wording
Reason: Blood collection tubes experienced an issue with separation and clotting
Code information: Lot Number: B2003399
Distribution pattern: US Nationwide distribution including in the states of IL, PA, VA, MO, NY.
Derived failure modes
-
Unknown
Blood collection tubes experienced an issue with separation and clotting