Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BD Latitude (DMS) -- Blood Glucose Monitor.

FDA Recall Z-0561-06 · Posted 2006-02-25

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeNBW
Date Initiated2006-01-05
Date Terminated2006-09-05
Product Quantity61,716 units

Reason for Recall

BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

Firm Action

Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006

Root Cause

Other

Distribution Pattern

The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022580BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEMBecton, Dickinson & CO · 2002-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑