OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Star
FDA device recall Z-1359-2012 · posted 2012-04-02 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- 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.
- Action taken
- 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 Strips and Ancillary Products. 2. Communicate this replacement program to their distribution centers and retail stores that have received OneTouch Verio"IQ Meters. Request that they return only OneTouch Verio"IQ Meters per their normal return procedures. 3. Once you received all of the OneTouch Verio"IQ Meters to be returned, call Inmar Corp. at 336-631-7744 for a Returned Goods Authorization (RGA) number and product return instructions. When product has been returned, a credit memo for an amount equivalent to the invoiced price of the returned product. No deductions will be allowed. If you have any questions about this action, please contact your LifeScan Sales Representative or call the LifeScan Customer Experience Line at: 1-800-600-7226, Option 1. Customers were advised that they can continue use of their affected product until an updated meter is provided free of charge. For questions regarding this recall call 408-942-5937.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 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
- Date initiated
- 2012-02-21
- Date posted
- 2012-04-02
- Date terminated
- 2013-02-05
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM (K110637) | Cilag GmbH International | 2011-09-07 |