Roche Diagnostics Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots 17592001, exp. 10/31/07, 17502002, exp. 10/31/07, 17733201, exp. 2/29/08, and 17733202, exp. 2/29/08.
Products Sold
Lots 17592001, exp. 10/31/07; 17502002, exp. 10/31/07; 17733201, exp. 2/29/08; and 17733202, exp. 2/29/08.
Roche Diagnostics Corp. is recalling Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Ele due to The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
Recommended Action
Per FDA guidance
The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.
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