Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic u

FDA device recall Z-2708-2014 · posted 2014-09-26 · Terminated

Recall details

Recalling firm

Dako North America Inc.

Reason for recall

Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejection of reagent bottles or inadequate aspiration of reagent if the instrument has also had a preventative maintenance or waste pump replacement, and the baseplate is not completely aligned.

Action taken

Dako North America sent an Urgent Medical Device Correction letter to all customers who were upgraded to the Dako Link 4.0.3 software that is used on the Dako Autostainer Link 48 and who also had preventative maintenance or a waste pump replacement. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed that Dako will contact customers to set up an appointment for a service visit in order to ensure that the instruments are running safely or reliably. Customers with questions are instructed to contact Dako.

Root cause

Software change control

Status

Terminated

Product code

KPA

Quantity affected

191 units total (57 units in US)

Distribution

Worldwide Distribution - US Nationwide in the states of AT, AU, BE, CA, CN, DE, DK, ES, Fl, FR, GB, IE, IT, NL, NO, SE, US, DZ, GR, IS, OM, SG, UY.

Date initiated

2014-08-29

Date posted

2014-09-26

Date terminated

2015-03-03

Location

Carpinteria, CA