Recalls / —

—#43937

Product

Roche brand Elecsys Troponin T; catalog number 2017644.

FDA product code

MMI — Immunoassay Method, Troponin Subunit

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K040733, K051752, K984105

Affected lot / code info

Lot 171924-02.

Why it was recalled

A false negative result may be reported.

Root cause (FDA determination)

Other

Action the firm took

Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-01-31

Posted by FDA

2006-02-09

Terminated

2006-04-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43937. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.