Recall Z-1293-03 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].
| Date | Oct 15, 2003 (initiated Sep 12, 2003) |
| Status | Terminated |
| Reason | Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch. |
| Root cause | Other |
| Action | Urgent recall letters dated 9/12/03 were sent to customers of 2 lots on 9/12/03 instructing them to cease using the recalled lots and to inform the attending physician of any patients diagnosed using these lots. Distributors were asked to forward the letter to all customers who had received CoaguChek test strips or system care products. A copy of the recall notification was sent to the entire professional customer list reminding them to always inspect the product for seal integrity. The recall was extended to all lots via 9/26/03 press release. Recall letters were sent to all professional |
| Quantity | 363628 |
| Distribution | United States, Australia, Austria, Belgium, Chile, Czech Republic, Greece, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland and the United Kingdom. |
| FDA record | Open on fda.gov |