One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to b
FDA device recall Z-0004-2009 · posted 2008-11-21 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 35308 vials
- Distribution
- Nationwide Distribution --- including Puerto Rico.
- Date initiated
- 2008-09-19
- Date posted
- 2008-11-21
- Date terminated
- 2010-12-27
- Location
- Milpitas, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K062195) | Lifescan, Inc. | 2006-08-16 |