Recall Z-1042-2009
Diasorin Inc. · initiated December 5, 2008
Product
Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.
Codes / lots: Serial numbers: 2229000828, 2229000829, 2229000839, 2229000857, 2229000859, 2229000926, 2229000972, 2229001196, and 2229001230.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1042-2009
- Initiated
- December 5, 2008
- Posted by FDA
- March 30, 2009
- Terminated
- May 22, 2012
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Quantity
- 9
- Distribution
- Worldwide Distribution -- USA including states of NC, NJ, PA, CA, WA, MO, UT, and OR and country of Canada.
- Recalling firm
- Diasorin Inc., Stillwater, MN