Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

The firm distributed an Urgent Recall Notification, dated 11/30/2021, to customers who purchased recalled product via first class mail. The notification informs customers that the firm is initiating a removal of Trilevel Serum Matrix Free from S-O2460605 kits due to product being compromised during shipment. Customers are instructed to immediately check their stock for affected product, quarantine any lot numbers associated with the recall, and destroy affected product. Customers were provided an Urgent Remedial Action Destruction Form to complete and return to the firm to indicate whether or not they possess recalled product and document product destruction. Completed forms are to be returned to the firm via email at [email protected] or by fax at 866-767-1290. If product was further distributed, customers are required to share the recall notification down the distribution chain. Customers with any questions about the recall are instructed to call 866-359-1704.