The Recall Desk

FDA (Devices) recall action 67152

Nipro Diagnostics, Inc. recalled 2 products on 2014-02-12

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-02-12
Critical
0
Units
606

Why these products were recalled

Manufactured with an incorrect factory set unit of measure.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2014-02-12

    Nipro Diagnostics Recalls TRUEtrack Blood Glucose Monitors Due to Unit Error

    Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken fr
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-02-12

    Nipro Diagnostics Recalls Blood Glucose Monitors With Incorrect Factory Settings

    Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor because they were manufactured with an incorrect factory set unit of measure.

    Product
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken
    Category
    Distribution
    1 state