Recall Z-1130-2013— Lifescan Inc
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: K072543. Product: LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. 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 recordK-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¿ Select Control Solution, Part Number/Model #: 02168902. 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.