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Terminated

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

FDA Recall Z-0856-2007 · Posted 2007-06-07

Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2007-03-05
Date Terminated2008-04-04
Product Quantityapproximately 300 lots

Reason for Recall

The front button covers may detach from the meter.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Product was distributed worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040814MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEMAbbott Laboratories · 2004-04-15K033845PRECISION XCEED DIABETES MONITORING SYSTEMAbbott Laboratories · 2004-01-08

Official Source

View FDA Recall →

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

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