Recalls / —

—#27063

Product

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

K984105

Affected lot / code info

All lots.

Why it was recalled

Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

Root cause (FDA determination)

Other

Action the firm took

An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

United States

Timeline

Recall initiated

2003-04-25

Posted by FDA

2003-05-29

Terminated

2003-06-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.