Recall Z-1303-04 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Roche Diagnostics Corp.
Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
| 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 | 197 boxes |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864082 | REFLOTRON(R) ALT (GPT) Boehringer Mannheim Corp., Dec 4, 1986 |