LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and M
FDA device recall Z-0452-2007 · posted 2007-01-05 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
- Action taken
- The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 26,398 units (both recall numbers Z-0452/3-2007
- Distribution
- Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.
- Date initiated
- 2006-09-29
- Date posted
- 2007-01-05
- Date terminated
- 2007-11-27
- Location
- Milpitas, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K022724) | Lifescan, Inc. | 2002-09-12 |