FDA Recall
Terminated
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
Recall: Z-1045-2009
·
Initiated November 25, 2008
Recall
- Recall Number
- Z-1045-2009
- Event Number
- 50519
- Firm
- Immuno Concepts Inc
- FEI Number
- 2918768
- Product Code
- LLL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 25, 2008
- Posted
- April 6, 2009
- Terminated
- November 17, 2009
- Address
- 9779 Business Park Dr, Ste D, Sacramento, CA, 95827-1715
Description
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
Reason
In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
Action
The firm has issued telephone calls, e-mails and notification letters to its consignees.
Distribution
Worldwide Distribution including USA, Australia, England, Sweden and Austria.
Quantity
25 kits