Recall Z-0572-05 ยท LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Diasorin Inc.
Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285
| Date | Mar 8, 2005 (initiated Sep 10, 2003) |
| Status | Terminated |
| Reason | Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results. |
| Root cause | Other |
| Action | Kit was initially placed on hold. Later Kit was discontinued and an alternate which would run correctly on the ETI-Max 3000 automated platform was found and offered to customers. |
| Quantity | 99 kits |
| Distribution | AL, CA, IL, KS, MA, MI & NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900688 | VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT Clinical Sciences, Inc., May 15, 1990 |