Recall Z-1359-2012 ยท LFR Glucose Dehydrogenase, Glucose
Lifescan Inc
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed by : LifeScan, Inc. Milpitas, CA 95035 for: LifeScan Europe Division of Cilag GmBH International 6300 Zug Switzerland Meter made in China. Intended to be used for the quantitative measurement of glu
| Date | Apr 2, 2012 (initiated Feb 21, 2012) |
| Status | Terminated |
| Reason | An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display. |
| Root cause | Software design |
| Action | Lifescan sent an Urgent Medical Device Voluntary Recall letter dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1. Identify and sequester all lots of OneTouch Verio"IQ Meters they have in inventory. UPC No. 353885007702 LifeScan Part No. 022267 NDC No. 53885026701 Note: Only OneTouch Verio"IQ Meters are subject to this notice. Please continue to sell all other OneTouch Brand products including OneTouch Verio" Test Strips and all OneTouch Ultra Brand Meters, Test Stri |
| Quantity | 101,841 units. 2-27-12 - this figure is an estimate and will be updated when more accurate number is received. |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110637 | ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM Cilag GmbH International, Sep 7, 2011 |