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Terminated

Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron HEA-214 meter, Optium Xido meter, Boots meter.

FDA Recall Z-0112-2008 · Posted 2008-02-14

Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeNBW
Date Initiated2007-08-02
Date Terminated2011-03-28
Product Quantity882,601 total meters distributed, 316,439 in the U.S. and 566,162 outside of the U.S. including Mexico and Canada

Reason for Recall

Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.

Firm Action

Abbott sent Urgent Medical Device Correction letters, dated 31Aug07, to registered users/customers via FedEx or mail. The letter instructs users to verify that their display is correct, and if not, to discontinue use and call Abbott Customer Care at 1-877-844-4404 for a new meter. Warranty kits will have fliers added to them to alert users. Email and telephone contacts may be made as needed. U.S. consignees and registered users will be contacted by letter, telephone call or visit starting 23Aug07. Worldwide, customer lists will be created and communications tracked according to local requirements. Abbott issued a Press Release August 31, 2007 also.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA, Canada, Mexico, Australia, Malaysia, Philippines, Germany, New Zealand, China, India, Singapore, Hong Kong, Taiwan, Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Peru, Puerto Rico, Uruguay, Venezuela, and Japan.

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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