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Terminated

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.

FDA Recall Z-0977-2007 · Posted 2007-06-28

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNHG
Date Initiated2007-05-15
Date Terminated2008-06-11
Product Quantity6051

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.

Firm Action

The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043175ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPERoche Diagnostics Corp. · 2004-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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