Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 462
FDA device recall Z-0572-05 · posted 2005-03-08 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFY
- Quantity affected
- 99 kits
- Distribution
- AL, CA, IL, KS, MA, MI & NJ
- Date initiated
- 2003-09-10
- Date posted
- 2005-03-08
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT (K900688) | Clinical Sciences, Inc. | 1990-05-15 |