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].
This recall has been terminated (originally issued November 30, 2006).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- October 18, 2006
- Posted
- November 30, 2006
- Terminated
- June 20, 2007
- Recall Number
- Z-0227-2007
- Quantity
- Approx 26,000,000 test strips to U.S. and 31,000,000 test strips Ex-U.S.
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide
Lot / Code Info
All lots.
Root Cause
Other
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.