Recall Z-0659-05 ยท NOM Antigen, Galactomannan, Aspergillus Spp.
Bio Rad Laboratories, Inc.
Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.
| Date | Mar 29, 2005 (initiated Jan 25, 2005) |
| Status | Terminated |
| Reason | New instructions to recommend against using samples with visibly high level of blood. |
| Root cause | Other |
| Action | Letters were sent to customers January 25-27, 2005 via overnight mail. Letters advised the customers of the issue and included a new package insert. The firm included a revised package insert to clarify precautions. The firm sent a CORRECTED COPY letter dated January 31, 2005 outlining the changes made in the product insert. |
| Quantity | 1547 kits |
| Distribution | Product was distributed to 93 hospitals and medical centers located throughout the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT Genetic Systems Corp., Jul 16, 1987 |