Recall Z-0668-2009
Dade Behring, Inc. · initiated June 23, 2008
Product
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Codes / lots: Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.
Reason for recall
Incorrect result: Potential for false elevation of CTnI results
FDA-determined cause: Nonconforming Material/Component
Action taken
Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.
Details
- Recall number
- Z-0668-2009
- Initiated
- June 23, 2008
- Posted by FDA
- January 28, 2009
- Terminated
- January 29, 2009
- Product code
- JHX – Fluorometric Method, Cpk Or Isoenzymes
- Quantity
- 5868 cartons
- Distribution
- Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
- Recalling firm
- Dade Behring, Inc., Newark, DE