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Terminated

Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.

FDA Recall Z-1001-2007 · Posted 2007-07-03

Recalling FirmBayer Healthcare LLC
Recall StatusTerminated
Product CodeLFR
Date Initiated2007-06-06
Date Terminated2007-11-30
Product Quantity16-Canadian Units only are affected

Reason for Recall

Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.

Firm Action

The firm began calling Canadian customers on or about 6/06/07 to inform them of the problem, to tell them that a meter with the correct measurement units will be sent to them, and to request that they return the meter currently in their possession.

Root Cause

Other

Distribution Pattern

Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080Bayer Healthcare · 2006-09-11

Official Source

View FDA Recall →

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

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