Recall Notification: Serum Tube (Lot Specific)
Greiner Bio-One is conducting a recall on the VACUETTE® 3.5mL CAT Serum Sep Clot Activator tube. During the tube assembly process, the VACUETTE® 3.5 mL CAT Serum 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 stated volume. The draw volume on damaged tubes may vary from a no-fill up to filling within specification. According to CLSI recommendation, fill volume should be in the range of +/-10 percent of the stated nominal draw volume.
The specific item and lot numbers affected are listed below. There have been no reports of serious injury.
Item | Lot number | Product description |
454067P | B190338E | VACUETTE® CAT 3.5 mL Serum Sep Clot Activator |
For additional information or questions, please contact Greiner Bio-One Technical Service at 1-800-515-8112, Monday through Friday 8am to 5pm eastern time.
A customer letter and product disposition letter are listed below for additional information which was sent to user in the mail.
Product Disposition Site Confirmation
FDA Status: Terminated
