Recalls / —

—#37505

Product

Access Immunoasay Systems Digoxin Reagent

FDA product code

KXT — Enzyme Immunoassay, Digoxin

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K925802

Affected lot / code info

Lots 323171; 416110; 417703; 419534

Why it was recalled

Variability in results on Patient and QC results of 20-25%, high and low.

Root cause (FDA determination)

Other

Action the firm took

Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2005-02-23

Posted by FDA

2005-03-08

Terminated

2005-09-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #37505. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.