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. 

Customer Letter

Product Disposition Site Confirmation

Underfill Study