CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-pat

FDA device recall Z-0227-2007 · posted 2006-11-30 · Terminated

Recall details

Recalling firm

Roche Diagnostics Corp.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GJS

Quantity affected

Approx 26,000,000 test strips to U.S. and 31,000,000 test strips Ex-U.S.

Distribution

Worldwide

Date initiated

2006-10-18

Date posted

2006-11-30

Date terminated

2007-06-20

Location

Indianapolis, IN

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