Recall Z-1576-05 ยท MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Diasorin Inc.
ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
| Date | Oct 1, 2005 (initiated Mar 9, 2004) |
| Status | Terminated |
| Reason | An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay. |
| Root cause | Other |
| Action | Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually. |
| Quantity | 128 |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.