Recall Z-2201-2020 ยท NBW System, Test, Blood Glucose, Over The Counter
Trividia Health, Inc.
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
| Date | Apr 20, 2020 |
| Status | Terminated |
| Reason | One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. |
| Root cause | Process control |
| Action | Trividia Health initiated the recall by public notice on 04/17/2020 and posted the notice on its website. The recall is being extended to the user level. Trividia Health has contacted its direct consignee (distributor) on 04/20/2020 by email and has issued a press release to notify consumers. The firm is requesting that the distributor contact its customers (pharmacists, DMEs, and consumers), who in turn are requested to contact their customers (users). Instructions for People with Diabetes: Determine whether you have the affected meter by obtaining the serial number from the serial number |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution including in the state of Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System Nipro Diagnostics, Inc., Mar 26, 2015 |