—#51478

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.

FDA product code: NHG — Enzyme Immunoassay, Cortisol, Salivary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K043175
Affected 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.

Why it was recalled

The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-05-15
Posted by FDA: 2007-06-28
Terminated: 2008-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.