Recall Z-0814-03 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Roche Diagnostics Corp.
CoaguChek Plus meter; catalog # 475729 and 12816001.
| Date | May 14, 2003 (initiated Mar 12, 2003) |
| Status | Terminated |
| Reason | High frequency signals from other medical or communications equipment will result in a variable positive bias in test results. |
| Root cause | Other |
| Action | Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory. |
| Quantity | 472 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860719 | BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) Biotrack, Inc., May 23, 1986 |