Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0703-05

Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the...

Diasorin Inc. / initiated 2004-05-20 / Terminated / root cause: software

Diasorin Inc. began a recall of Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate... on . The reason FDA records is "When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0703-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Diasorin Inc.
Product
Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.
Product code
JTC Device, Microtiter Diluting/Dispensing
Reason for recall
When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added.
Root cause tag
software
FDA root cause
Other
Action
Customers were notified by phone and informed of the problem and recommended users to use only the newer wash program which is identified is a 'W' in front of the program.
Quantity in commerce
9
Distribution
CA, FL, NH, PA, SD, TX, WA
Product codes and lots
version 7