Recall Z-0227-2007 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
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].
| Date | Nov 30, 2006 (initiated Oct 18, 2006) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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 let |
| Quantity | Approx 26,000,000 test strips to U.S. and 31,000,000 test strips Ex-U.S. |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930454 | BOEHRINGER MANNHEIM COAGUCHEK SYSTEM Boehringer Mannheim Corp., Aug 5, 1993 |
| K962571 | COAGUCHEK PST SYSTEM Boehringer Mannheim Corp., Apr 22, 1997 |
| K974569 | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING Boehringer Mannheim Corp., Jan 9, 1998 |
| K994349 | COAGUCHEK S SYSTEM, MODEL 2138280 Roche Diagnostics Corp., Sep 6, 2000 |