Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
This recall has been terminated (originally issued January 28, 2009).
- Company
- Dade Behring Inc.
- Recall Initiated
- June 23, 2008
- Posted
- January 28, 2009
- Terminated
- January 29, 2009
- Recall Number
- Z-0668-2009
- Quantity
- 5868 cartons
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect result: Potential for false elevation of CTnI results
Distribution
Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
Lot / Code Info
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.
Root 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.