CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report

MooreMedical Supporting Health & Care...MooreBrand Blood recalled

Nipro Diagnostics is recalling MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing, distributed nationwide in the US. The recall was initiated on 2 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFinished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.

Quantity recalled105

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0910-2014
FDA event ID: 67152
Recalling firm: Nipro Diagnostics, Ft Lauderdale, FL
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2013
FDA classified: 3 Feb 2014
Reported: 12 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

2 Oct 2013	Recall initiated by company
3 Feb 2014	Classified by FDA	+124 days
12 Feb 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Manufactured with an incorrect factory set unit of measure.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Hawaii Puerto Rico

Questions about this recall

Is MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing recalled?

Yes. Nipro Diagnostics recalled MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing on 2 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0910-2014.

Why was it recalled?

Manufactured with an incorrect factory set unit of measure.

Which lots are affected?

Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nipro Diagnostics

All 3

Reported	Class	Recall	Company	Reason	Where
12 Feb 2014Device	CLASS II	MooreMedical Supporting Health & Care...MooreBrand Blood recalled	Nipro Diagnostics	Other	Nationwide
24 Apr 2013Device	CLASS II	Duane Reade TRUEtrack monitor kit recalled by Nipro Diagnostics	Nipro Diagnostics	Temperature Abuse	Nationwide

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