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.
Recall
- Recall Number
- Z-2201-2020
- Event Number
- 85535
- Firm
- Trividia Health, Inc.
- FEI Number
- 1000113657
- Product Code
- NBW
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 20, 2020
- Terminated
- June 1, 2021
- Address
- 2400 NW 55th Ct, Ft Lauderdale, FL, 33309-2672
Description
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.
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.
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 label on the back of the meter (TA1548753) and visiting www.TrividiaHealth.com/air-product-notice or by calling Trividia Health toll-free at 1-800-518-5726, Monday-Friday, 8AM-8PM EST.(See page 4 for images of the meter and meter labels). Trividia Health will verify the affected meter by serial number and will expedite return and replacement of the meter at no charge to you. Discontinue use of the meter immediately if it is determined you have the affected meter. You may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this recall, while waiting for your replacement meter to arrive. Only use test strips that are intended for use with your meter. Instructions for Health Care Professionals: Determine whether you have or may have the affected meter in inventory by examining the kit lot number (KW0135) and meter serial number (TA1548753) printed on the outer case/shipper label or on the side of the individual meter box. (See page 3 for images of these labels). If you have any product from lot KW0135, you may have the affected meter. Please check your inventory and product labels to determine if you have meter serial number TA1548753. If you have this meter in inventory, please contact Trividia Health toll-free at 1-800-518-5726, Monday-Friday, 8AM-8PM EST to expedite return and replacement of the meter. Please advise any
US Nationwide distribution including in the state of Florida.
1 unit