Recall Z-0909-2014— Nipro Diagnostics, Inc.

Name: FDA recall Z-0909-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-02

Class II · Terminated

Class II FDA medical device recall by Nipro Diagnostics, Inc., initiated 2013-10-02, terminated 2016-01-28. It names one FDA 510(k) clearance: K090495. Product: 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: Manufactured with an incorrect factory set unit of measure..

Recalling firm: Nipro Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-02
Terminated: 2016-01-28
Firm location: Ft Lauderdale, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K090495 — TRUEBALANCE BLOOD GLUCOSE SYSTEMHome Diagnostics, Inc.·cleared 2009-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.