Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xcee

FDA device recall Z-0112-2008 · posted 2008-02-14 · Terminated

Recall details

Recalling firm

Abbott Diabetes Care, Inc.

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.

Action taken

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

Status

Terminated

Product code

NBW

Quantity affected

882,601 total meters distributed, 316,439 in the U.S. and 566,162 outside of the U.S. including Mexico and Canada

Distribution

Worldwide Distribution - USA, Canada, Mexico, Australia, Malaysia, Philippines, Germany, New Zealand, China, India, Singapore, Hong Kong, Taiwan, Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuado

Date initiated

2007-08-02

Date posted

2008-02-14

Date terminated

2011-03-28

Location

Alameda, CA

Related 510(k) clearances