Device product
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
Z-0818-2020
Product summary
- Event
- Event 84536
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,002,000 tubes
- Official record key
device-enforcement:Z-0818-2020
Official wording
Reason: The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.
Code information: DI: 29120049204476, Lot number B190338E
Distribution pattern: Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Derived failure modes
-
Unknown
The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.