Z-0818-2020 Class II Terminated
FDA device recall Z-0818-2020 was initiated by Greiner Bio-One North America, Inc. on November 25, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated October 5, 2020). Affected quantity: 1,002,000 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- November 25, 2019
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,002,000 tubes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Code Information
DI: 29120049204476, Lot number B190338E