TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.
Recall
- Recall Number
- Z-2881-2016
- Event Number
- 74805
- Firm
- Trividia Health
- FEI Number
- 1000113657
- Product Code
- NBW
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 28, 2016
- Address
- 2400 NW 55th Ct, Fort Lauderdale, FL, 33309-2672
Description
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.
Product gives incorrect low blood glucose levels.
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: [email protected].
Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.
5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally