Recall Z-0736-2007 ยท KXT Enzyme Immunoassay, Digoxin
Roche Diagnostics Corp.
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
| Date | Apr 13, 2007 (initiated Mar 16, 2007) |
| Status | Terminated |
| Reason | The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots. |
| Root cause | Other |
| Action | A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots. |
| Quantity | 4,735 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851032 | COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C Roche Diagnostic Systems, Inc., Apr 3, 1985 |