Roche Diagnostics Corp. Elecsys Troponin T STAT; catalog number 2017423 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Elecsys Troponin T STAT; catalog number 2017423
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Roche Diagnostics Corp. is recalling Elecsys Troponin T STAT; catalog number 2017423 due to Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
Recommended Action
Per FDA guidance
An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.
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