Elecsys Troponin T; catalog number 2017644
This recall has been terminated (originally issued May 29, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- April 25, 2003
- Posted
- May 29, 2003
- Terminated
- June 19, 2003
- Recall Number
- Z-0870-03
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
Distribution
United States
Lot / Code Info
All lots.
Root Cause
Other
Action Taken
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.
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