RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
This recall has been terminated (originally issued April 6, 2009).
- Company
- Immuno Concepts Inc
- Recall Initiated
- November 25, 2008
- Posted
- April 6, 2009
- Terminated
- November 17, 2009
- Recall Number
- Z-1045-2009
- Quantity
- 25 kits
- Firm Location
- Sacramento, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution including USA, Australia, England, Sweden and Austria.
Lot / Code Info
Kit Catalog Number 7096-09, Lot Number 0821407 and Kit Catalog Number 7696-09, Lot Number 0821404.
Root Cause
Process control
Action Taken
The firm has issued telephone calls, e-mails and notification letters to its consignees.