Recalls / —

—#26486

Product

CoaguChek PT test strips, sold in 12 pack.

FDA product code

JPA — System, Multipurpose For In Vitro Coagulation Studies

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K974569

Affected lot / code info

lot 533

Why it was recalled

Discrepancy between INR and the % Quick displayed on the meter.

Root cause (FDA determination)

Other

Action the firm took

Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

Germany

Timeline

Recall initiated

2003-02-20

Posted by FDA

2003-04-10

Terminated

2003-11-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26486. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.