—#48950

Product

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 [packaged 12 strips per box].

FDA product code: GJS — Test, Time, Prothrombin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K930454, K962571, K974569, K994349
Affected lot / code info: All lots.

Why it was recalled

Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.

Root cause (FDA determination)

Other

Action the firm took

A press release was issued by the firm on 10/19/06. The recall letter dated 10/19/06 sent to distributors who sell to home users instructs them to notify their home users and to discard any of product 3116239 in stock. The recall letter dated 10/19/06 to to home users, instructs them to discontinue use of, and to discard, their test strips and to contact their health care professional. The device correction letter dated 10/19/06 to distributors to professional users instructs them to notify customers and provides instructions for duplicate testing in laboratories. The device correction letter dated 10/19/06 to health care professionals asks that they follow-up with their home users to ensure they follow the instructions to cease home use and provides instructions for dupicate testing in laboratories.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2006-10-18
Posted by FDA: 2006-11-30
Terminated: 2007-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.