ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.1

FDA device recall Z-0147-2008 · posted 2007-11-07 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

Reason for recall

Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.

Action taken

Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level.

Root cause

Software change control

Status

Terminated

Product code

JJE

Quantity affected

89 units.

Distribution

Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany,

Date initiated

2007-09-05

Date posted

2007-11-07

Date terminated

2010-10-04

Location

Irving, TX