Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.
This recall has been terminated (originally issued June 28, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 15, 2007
- Posted
- June 28, 2007
- Terminated
- June 11, 2008
- Recall Number
- Z-0977-2007
- Quantity
- 6051
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
Distribution
Nationwide.
Lot / Code Info
Lots 17592001, exp. 10/31/07; 17502002, exp. 10/31/07; 17733201, exp. 2/29/08; and 17733202, exp. 2/29/08.
Root Cause
Other
Action Taken
The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.
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