Recall Z-1364-04 · MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Roche Molecular Systems Inc
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV MonitorTest, Export, RUO.
| Date | Aug 19, 2004 (initiated Jul 7, 2004) |
| Status | Terminated |
| Reason | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection. |
| Root cause | Other |
| Action | With respect to U.S distribution, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution center, Roche Diagnostics Corporation of Indianapolis, IN. With respect to overseas distributors, email/letter on 6/24/04 to the local safety officers and general managers stationed at the affiliated distribution centers. Roche stated that the local safety officer is responsible to communicate the advisory both to the customers/end-users and the regulatory authority of the country. On July 6, 2004, a Revised Important Product Advice Notice w |
| Quantity | 172 kits |
| Distribution | ♦ Amplicor CT/NG CT Detection Kit, Lot No.E12231, Material No.20759392018, Expiration 2/2005 , Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor CT/NG NG Detection Kit, Lot No.E12647, Material No.20759406018, Expiration 2/2005, Shipp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.