Recall Z-0452-2007
Lifescan Inc · initiated September 29, 2006
Product
LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
Codes / lots: Lot number 2627353, part number 020-052-01
Reason for recall
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0452-2007
- Initiated
- September 29, 2006
- Posted by FDA
- January 5, 2007
- Terminated
- November 27, 2007
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 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.
- Recalling firm
- Lifescan Inc, Milpitas, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0453-2007 | LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50…Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. | 09/29/2006Terminated |