—#26081

Product

CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

FDA product code: JPA — System, Multipurpose For In Vitro Coagulation Studies
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K983892
Affected lot / code info: All units.

Why it was recalled

High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

Root cause (FDA determination)

Other

Action the firm took

Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern: United States

Timeline

Recall initiated: 2003-03-12
Posted by FDA: 2003-05-14
Terminated: 2005-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #26081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.