FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx t
FDA device recall Z-1245-2013 · posted 2013-05-09 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
- Action taken
- Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 335,273 meters; 209,336 remain at firm.
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-04-15
- Date posted
- 2013-05-09
- Date terminated
- 2015-08-03
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM (K120568) | Abbott Diabetes Care, Inc. | 2012-03-29 |