One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
- Company
- Lifescan Inc
- Recall Initiated
- September 19, 2008
- Posted
- November 21, 2008
- Terminated
- December 27, 2010
- Recall Number
- Z-0004-2009
- Quantity
- 35308 vials
- Firm Location
- Milpitas, CA
Reason for Recall
Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
Distribution
Nationwide Distribution --- including Puerto Rico.
Lot / Code Info
Lot number 2829235
Root Cause
Process control
Action Taken
Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affected Lot 2829235; request all recalled inventory from customers; call Carolina Logistics for an RGA; and when only the affected returned product is received, a credit will be issued.