FDA Recall Terminated

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

Recall: Z-1042-2009 · Initiated December 5, 2008

Recall

Recall Number
Z-1042-2009
Event Number
50704
Firm
Diasorin Inc.
FEI Number
2182595
Product Code
JJQ
Status
Terminated
Root Cause
Device Design
Initiated
December 5, 2008
Posted
March 30, 2009
Terminated
May 22, 2012
Address
1951 Northwestern Ave S, Stillwater, MN, 55082-7536

Description

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

Reason

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.

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.

Distribution

Worldwide Distribution -- USA including states of NC, NJ, PA, CA, WA, MO, UT, and OR and country of Canada.

Quantity

9