Recall Z-0542-04 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
Hardy Media Inc Dba Hardy Diag
Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338
| Date | Feb 24, 2004 (initiated Dec 31, 2003) |
| Status | Terminated |
| Reason | Mislabeled. |
| Root cause | Other |
| Action | Customers were first notified by telephone on 12/31/2003. Then customers are mailed a sigh\ned recall letter via first class mail. All customers will be contacted by telephone to reconcile returns. |
| Quantity | 39 bottles of Z71 and 6 bottles of Z72 |
| Distribution | TX, CA, ID, Puerto Rico, KS, WY, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.