Summary
Becton, Dickinson and Company (BDX) announced on July 23, 2003, a voluntary recall in Canada of three specific lots of BDTM Test Strips for the BD LatitudeTM Diabetes Management System. This recall, initiated following an internal quality review, addresses potential accuracy issues with readings at low blood glucose levels, particularly for asymptomatic hypoglycemic patients. The affected distribution was limited to Canada and represents a small portion of overall test strip production. While BD has not received reports of serious injuries related to these lots, the company is working with Health Canada and the U.S. Food and Drug Administration (FDA). The sales value of the recalled strips is approximately $400,000, and the anticipated costs are not expected to be significant, though they will impact the company's third-quarter results. This action underscores BD's commitment to quality and patient safety in its diabetes management products.
Key Highlights
- 1Voluntary recall of three lots of BDTM Test Strips for the BD LatitudeTM Diabetes Management System in Canada.
- 2Recall initiated due to test strips not meeting quality and performance specifications, specifically concerning accuracy at low blood glucose levels.
- 3Affected distribution was limited solely to Canada.
- 4Sales value of recalled strips is approximately $400,000.
- 5Anticipated recall costs are not expected to be significant and will be reflected in Q3 2003 results.
- 6BD has not received any reports of serious injury resulting from the recalled test strips.
- 7Company is coordinating with Health Canada and the U.S. FDA regarding this corrective action.