FDAFDA · Food and drugs·Recall number Z-0910-2014
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 from finger or forearm.
Published February 12, 2014 · Recall initiated: October 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Manufactured with an incorrect factory set unit of measure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nipro Diagnostics, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
- Lot
- Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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