Recall Z-1045-2009
Immuno Concepts Inc · initiated November 25, 2008
Product
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
Codes / lots: Kit Catalog Number 7096-09, Lot Number 0821407 and Kit Catalog Number 7696-09, Lot Number 0821404.
Reason for recall
In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
FDA-determined cause: Process control
Action taken
The firm has issued telephone calls, e-mails and notification letters to its consignees.
Details
- Recall number
- Z-1045-2009
- Initiated
- November 25, 2008
- Posted by FDA
- April 6, 2009
- Terminated
- November 17, 2009
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Quantity
- 25 kits
- Distribution
- Worldwide Distribution including USA, Australia, England, Sweden and Austria.
- Recalling firm
- Immuno Concepts Inc, Sacramento, CA