Recall Z-1129-2013— Lifescan Inc

Name: FDA recall Z-1129-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-25

Class II · Terminated

Class II FDA medical device recall by Lifescan Inc, initiated 2013-02-25, terminated 2013-10-23. It names one FDA 510(k) clearance: K062195. Product: LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.. Reason: When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly..

Recalling firm: Lifescan Inc
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Terminated: 2013-10-23
Firm location: Milpitas, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K062195 — MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.·cleared 2006-08-16

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

LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.

Reason for recall

When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.

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