103811 - Accu-Chek Guide Kit

Summary of Recall: Roche Diabetes Care has received three customer complaints, including one US complaint, in which the meter was reading in the incorrect unit of measure. The complaints were reported to FDA as quality issues via the Medical Device Reporting program. The resulting Roche complaint investigations indicated that the above Accu-Chek Guide systems were configured incorrectly, and thus show the results in mmol/L rather than in the labeled measuring unit, mg/dL. It becomes visible once a blood glucose measurement is taken and the user could recognize that the result is displayed mmol/L rather than mg/dL. Roche Diabetes Care has conducted an in-depth evaluation of the underlying root cause of the above-described issue and has corrected the issue to prevent recurrence.

Product Description: The affected products are those with identifying attributes seen below.

Hazard: This misconfiguration may result in customers perceiving wrong units of measure, and/or interpreting a result as approximately 18 times lower than the actual blood glucose. In the worst case, these misleading displayed results, in the wrong unit of measure, may trigger an inappropriate treatment decision (consumption of carbohydrates) with potentially severe consequences.

Manufacturer: Roche Diabetes Care

UPCs Carried by Meijer:

What You Should Do: Consumers who have purchased this product should discontinue use immediately and return the product to the nearest Meijer store for a full refund.

Consumer Contact Information: Consumers with questions regarding this recall can contact Accu-Chek Customer Care at 1-800-858- 8072.

Consumers with questions or concerns about their health should contact their Physician.