Recalls / —

—#44150

Product

Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.

FDA product code

LFW — Fluorescence Polarization Immunoassay, Tobramycin

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K912143

Affected lot / code info

Lot 56292625; exp. 05/31/07.

Why it was recalled

May have tobramycin over-recovery at the trough level.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via phone and faxed recall letter on or about 2/10/06.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-02-10

Posted by FDA

2006-02-28

Terminated

2006-06-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #44150. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.