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Ascensia Contour Blood Glucose Monitoring System ( Bayer… recallZ-1001-2007 · Bayer Healthcare LLC · initiated Jun 6, 2007

Terminated All recalls posted in July 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bayer Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1001-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 6, 2007
Posted by the FDA
Jul 3, 2007
Recalling firm
Bayer Healthcare LLC
Quantity
16-Canadian Units only are affected
Product code
LFR
FDA submissions
K062058
Distribution
Canada.

Product description

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

Code information (models, lots, serial numbers)

NO USA Units Affected: Serial numbers 1475139, 1688643, 1841620, 1852071, 2064303, 2064306, 2064329, 2064601, 2086449, 2203283, 2221308, 2263059, 2263260, 2280056, 2317037 and 2319010.

Other devices under the same FDA submission

9 devices cleared under K062058 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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