Recall Z-1202-03 ยท DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Varian, Inc.
On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label
| Date | Sep 12, 2003 (initiated Jul 18, 2003) |
| Status | Terminated |
| Reason | Stability in question. |
| Root cause | Other |
| Action | Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement. |
| Quantity | 11847 kits (50 units/kit) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.