Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
- Company
- Zeus Scientific, Inc.
- Recall Initiated
- February 24, 2000
- Posted
- July 30, 2003
- Terminated
- October 25, 2004
- Recall Number
- Z-1065-03
- Quantity
- 205
- Firm Location
- Branchburg, NJ
Reason for Recall
The high positive control/low positive standard ratio recovering too low.
Distribution
The two lots were shipped to St. Louis, MO. No subrecall was initiated.
Lot / Code Info
Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491 Exp. 10-02-2001; 090K6483 Exp. 5-31-2002.
Root Cause
Other
Action Taken
Recall letters sent out via DHL on 2/24/2000
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