Dade Behring, Inc. Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Brand
Dade Behring, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Dade Behring, Inc. is recalling Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. due to Incorrect result: Potential for false elevation of CTnI results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect result: Potential for false elevation of CTnI results
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026