Home / Recalls / Nipro Diagnostics, Inc. / Z-0909-2014

Z-0909-2014 Class II Terminated

Recalled by Nipro Diagnostics, Inc. — Ft Lauderdale, FL

FDA device recall Z-0909-2014 was initiated by Nipro Diagnostics, Inc. on October 2, 2013 and is designated Class II. Reason for recall: Manufactured with an incorrect factory set unit of measure. The recall status is terminated (terminated January 28, 2016). Affected quantity: 501.

Recall Details

Product Type: Devices
Report Date: February 12, 2014
Initiation Date: October 2, 2013
Termination Date: January 28, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 501

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.

Reason for Recall

Manufactured with an incorrect factory set unit of measure.

Distribution Pattern

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.

Code Information

Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.