Recall Z-1302-04 ยท CKD Hydrazone Colorimetry, Alt/Sgpt
Roche Diagnostics Corp.
Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
| Date | Jul 31, 2004 (initiated Jul 14, 2004) |
| Status | Terminated |
| Reason | Coating defect may result is falsely decreased patient and/or control results. |
| Root cause | Other |
| Action | Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips. |
| Quantity | 166 boxes |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870246 | REFLOTRON(R) AST (GOT) Boehringer Mannheim Corp., Feb 18, 1987 |