| Date Initiated by Firm |
April 20, 2020 |
| Create Date |
June 01, 2020 |
| Recall Status1 |
Terminated 3 on June 01, 2021 |
| Recall Number |
Z-2201-2020 |
| Recall Event ID |
85535 |
| 510(K)Number |
K150052
|
| Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
|
| Product |
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. |
| Code Information |
Serial Number TA1548753 |
Recalling Firm/
Manufacturer |
Trividia Health, Inc.
2400 NW 55th Ct
Ft Lauderdale FL 33309-2672
|
| For Additional Information Contact |
Annmarie Ramos
800-342-7226 Ext. 3190
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
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 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 |
| Quantity in Commerce |
1 unit |
| Distribution |
US Nationwide distribution including in the state of Florida. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = Nipro Diagnostics, Inc
|
