Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1042-2009

Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for...

Diasorin Inc. / initiated 2008-12-05 / Terminated / root cause: design

Diasorin Inc. began a recall of Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use on . The reason FDA records is "DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1042-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Diasorin Inc.
Product
Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall
DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer.
Root cause tag
design
FDA root cause
Device Design
Action
DiaSorin Inc authorized Field Service Engineer has visited the sites and performed the necessary field correction. Upon completion of their work, the field service engineer generated a Field Service Report and a copy was left with the customer.
Quantity in commerce
9
Distribution
Worldwide Distribution -- USA including states of NC, NJ, PA, CA, WA, MO, UT, and OR and country of Canada.
Product codes and lots
Serial numbers: 2229000828, 2229000829, 2229000839, 2229000857, 2229000859, 2229000926, 2229000972, 2229001196, and 2229001230.