Z-1001-2007

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

Name: Z-1001-2007 Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units...
Creator: Bayer Healthcare LLC
Published: 2007-06-06
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2007-06-06 / Terminated

FDA source

Bayer Healthcare LLC began a recall of Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected--- on 2007-06-06. The reason FDA records is "Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1001-2007
Status: Terminated
Initiated: 2007-06-06
Posted: 2007-07-03
Terminated: 2007-11-30
Recalling firm: Medrad, Inc.
Product: Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---.
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.
FDA root cause: Other
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.
Quantity in commerce: 16-Canadian Units only are affected
Distribution: Canada.
Product codes and lots: NO USA Units Affected: Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010.

Product code LFR

K062058Class IIAscensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Bayer Healthcare / cleared 2006-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)