MooreMedical Supporting Health & Care...MooreBrand Blood… recallZ-0909-2014 · Nipro Diagnostics, Inc. · initiated Oct 2, 2013
Class II Terminated All recalls posted in February 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nipro Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Manufactured with an incorrect factory set unit of measure.
FDA root cause category: Software design (manufacturing process)
What the company is doing
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.
Recall details
- Recall number
- Z-0909-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 2, 2013
- Posted by the FDA
- Feb 3, 2014
- Recalling firm
- Nipro Diagnostics, Inc.
- Quantity
- 501
- Product code
- NBW
- FDA submissions
- K090495
- 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 description
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 from finger or forearm.
Code information (models, lots, serial numbers)
Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.
Other devices under the same FDA submission
3 devices cleared under K090495 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRUEbalance TRUEbalance BLOOD GLUCOSE MONITORING SYSTEMTrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter55 reports
- TRUEbalance TRUEbalance 50 Blood Glucose Test StripsTrividia Health, Inc. · Glucose Oxidase, Glucose11 reports
- TRUEbalance TRUEbalance 10 Blood Glucose Test StripsTrividia Health, Inc. · Glucose Oxidase, Glucose1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 67152).
- Z-0910-2014 · TerminatedMooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 333…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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