ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-l

FDA device recall Z-0728-2007 · posted 2007-04-07 · Terminated

Recall details

Recalling firm

Abbott Laboratories

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.

Action taken

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

Status

Terminated

Product code

CHP

Quantity affected

1,944 kits

Distribution

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

Date initiated

2007-02-19

Date posted

2007-04-07

Date terminated

2008-01-09

Location

Abbott Park, IL