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.
This recall has been terminated (originally issued November 25, 2019).
- Recall Initiated
- November 25, 2019
- Terminated
- October 5, 2020
- Recall Number
- Z-0818-2020
- Quantity
- 1,002,000 tubes
- Firm Location
- Monroe, NC
- Official Source
- View on FDA website ↗
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
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Lot / Code Info
DI: 29120049204476, Lot number B190338E
Root Cause
Process control
Action Taken
The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product.
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