ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Labora

FDA device recall Z-1392-2009 · posted 2009-05-27 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.

Action taken

Consignees were contacted by phone and sent an "Urgent Field Safety Notice Product Recall" dated February 26, 2009. The letter informed users of the problem and detailed how to identify and discard the affected product. In addition, Abbott Laboratories asked the consignees to send a copy of the letter to any laboratory to which they may have forwarded any of affected lots. Abbott sent a second letter dated May 12, 2009 informing consignees of a recall expansion of additional affected lots. The recall was again expanded on 12/17/09 for an addtional 40 lots of reaction vessels. For additional information, contact Abbott Labs at 1-877-4ABBOTT.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJE

Quantity affected

27,163 cartons

Distribution

Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kon

Date initiated

2009-02-26

Date posted

2009-05-27

Date terminated

2010-11-04

Location

Abbott Park, IL