ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
FDA Recall Z-0728-2007 · Posted 2007-04-07
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeCHP
Date Initiated2007-02-19
Date Terminated2008-01-09
Product Quantity1,944 kits
Reason for Recall
A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.
Firm Action
Abbott initiated a field correction recall by letter dated 2/19/07 to all customers receiving the affected reagent. The accounts were informed of the incorrectly configured reagent kits. The accounts were requested to assess the inventory for the affected lots of reagents, inspect each kit and destroy any kits incorrectly configured, recording the number of kits inspected and the number of kits discarded on the customer reply form and faxing it to Abbott by 3/2/07, indicating that the letter was received and understood. Replacement kits will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
Root Cause
Other
Distribution Pattern
Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Chile, Uruguay, Argentina, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.