Recall Z-1153-2013— Nova Biomedical Corporation

Name: FDA recall Z-1153-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-25

Class II · Terminated

Class II FDA medical device recall by Nova Biomedical Corporation, initiated 2013-02-25, terminated 2014-09-26. It names one FDA 510(k) clearance: K063821. Product: Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214. Reason: Glucose test strips reports no result message when tested.

Recalling firm: Nova Biomedical Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Terminated: 2014-09-26
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K063821 — NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corp.·cleared 2007-01-24

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

Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214

Reason for recall

Glucose test strips reports no result message when tested

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