Z-2201-2020Class II

True Metrix Self Monitoring Blood Glucose System -

Name: Z-2201-2020 True Metrix Self Monitoring Blood Glucose System -
Creator: Trividia Health, Inc.
Published: 2020-04-20
License: https://open.fda.gov/license/

Trividia Health, Inc. / initiated 2020-04-20 / Terminated / root cause: manufacturing process

FDA source

Trividia Health, Inc. began a recall of TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole... on 2020-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2201-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Posted: 2020-06-01
Terminated: 2021-06-01
Recalling firm: Trividia Health, Inc.
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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Serial Number TA1548753

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2201-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2201-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-01

Product code NBW

K150052Class IITRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring SystemNipro Diagnostics, Inc. / cleared 2015-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)