Z-2201-2020 Class II Terminated
FDA device recall Z-2201-2020 was initiated by Trividia Health, Inc. on April 20, 2020 and is designated Class II. 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 displa… The recall status is terminated (terminated June 1, 2021). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 20, 2020
- Termination Date
- June 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product 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.
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.
Distribution Pattern
US Nationwide distribution including in the state of Florida.
Code Information
Serial Number TA1548753