—#46263

Product

Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.

FDA product code: CIC — Cresolphthalein Complexone, Calcium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K041009
Affected lot / code info: Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).

Why it was recalled

Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-06-07
Posted by FDA: 2006-06-27
Terminated: 2008-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46263. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.