Recall Z-2883-2016 ยท NBW System, Test, Blood Glucose, Over The Counter
Trividia Health
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.
| Date | Jun 28, 2016 |
| Status | Open, Classified |
| Reason | Product gives incorrect low blood glucose levels. |
| Root cause | Nonconforming Material/Component |
| Action | 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 w |
| Quantity | 5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally |
| Distribution | 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090495 | TRUEBALANCE BLOOD GLUCOSE SYSTEM Home Diagnostics, Inc., Mar 27, 2009 |