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Precision Xtra Blood Glucose monitoring system. Individual… recallZ-0856-2007 · Abbott Diabetes Care, Inc. · initiated Mar 5, 2007

Terminated All recalls posted in June 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 Abbott Diabetes Care, Inc. 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

The front button covers may detach from the meter.

FDA root cause category: Other

What the company is doing

The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.

Recall details

Recall number
Z-0856-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 5, 2007
Posted by the FDA
Jun 7, 2007
Recalling firm
Abbott Diabetes Care, Inc.
Quantity
approximately 300 lots
Product code
NBW
FDA submissions
K033845, K040814
Distribution
Product was distributed worldwide.

Product description

Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.

Code information (models, lots, serial numbers)

Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid.

Other devices under the same FDA submission

1 device cleared under K033845, K040814 — 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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