Z-0910-2014Class II

MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use...

Name: Z-0910-2014 MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use...
Creator: Nipro Diagnostics, Inc.
Published: 2013-10-02
License: https://open.fda.gov/license/

Trividia Health, Inc. / initiated 2013-10-02 / Terminated / root cause: software

FDA source

Nipro Diagnostics, Inc. began a recall of MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS... on 2013-10-02. FDA classified it as Class II and gives the reason as "Manufactured with an incorrect factory set unit of measure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0910-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-02
Posted: 2014-02-03
Terminated: 2016-01-28
Recalling firm: Trividia Health, Inc.
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 from finger or forearm.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Manufactured with an incorrect factory set unit of measure.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.
Quantity in commerce: 105
Distribution: 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.
Product codes and lots: Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0910-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0909-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0910-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code NBW

K032657Class IITruetrack Smart System Blood Glucose Meter, Blood Glucose Test Strips, and Glucose Control Solutions (Low and High)Home Diagnostics, Inc. / cleared 2004-03-24

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)