Recall Z-2882-2016

Reason for recall

Product gives incorrect low blood glucose levels.

FDA-determined cause: Nonconforming Material/Component

Action taken

The firm, Trividia, issued a press release on 06/28/2016 that instructed users to locate the test strip lot number on product on hand in order to determine if they possess affected product. Customers were instructed to contact Stericycle at 1-888-835-2723 or check online at www.trividiahealth.com/product-notice to see if their inventory was affected by the recall. Any strips under recall will be returned for disposal and replaced with no charge. In addition, the firm sent an "Urgent Medical Device Voluntary Recall" notice to customers addressing the recall and steps to follow. The customers were instructed to identify affected product using the same method: contacting Stericycle at 1-888-835-2723 or checking www.trividiahealth.com/product-notice to see if the product in possession was from affected lots; to notify patients that they may continue use of TRUEread, TRUEtrack, TRUEbalance, and TRUEtest strips not under recall, and to use them with the appropriate meter. Pharmacists/DME providers were instructed to call Stericycle if health care professionals contacted them regarding the recall. Distributors were requested to check their meter and strip inventories to see if they had any affected lots. Distributors were instructed to notify their own customers of the recall and collect product that is affected by the recall. Once all affected product is received by customers, distributors need to call Stericycle to obtain prepaid return labels. All returned product will be replaced at no charge. If you have any questions, contact Vice President of Marketing, at (800) 342-7226 ext. 2183 or email: LNardi@trividiahealth.com.