Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL).
FDA device recall Z-0699-2008 · posted 2008-02-01 · Terminated
Recall details
- Recalling firm
- ARKRAY USA INC.
- Reason for recall
- Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.
- Action taken
- On Friday, November 14, 2007 the recalling firm notified their distributors via telephone and email to inform them of the device defect and replaced all devices still in inventory. The distributors were also instructed to inform all of their customers of the issue and offer replacement product. Additionally, replacement will be offered to any end user that calls customer service about the issue. To reach ARKRAY use 1-800-818-8877 extension 3121 for replacement product.
- Root cause
- Process design
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 4,920
- Distribution
- Nationwide including the states of CA, FL, GA, IL, IN, MA, MI, MS, NC, NJ, OH, PA, and TX
- Date initiated
- 2007-11-16
- Date posted
- 2008-02-01
- Date terminated
- 2008-10-30
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 (K011233) | Apex BioTechnology Corp. | 2001-05-18 |
| GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM (K002621) | Apex BioTechnology Corp. | 2001-01-22 |