Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
- Company
- Zeus Scientific, Inc.
- Recall Initiated
- November 9, 2001
- Posted
- July 19, 2003
- Terminated
- October 3, 2006
- Recall Number
- Z-1031-03
- Quantity
- 505
- Firm Location
- Branchburg, NJ
Reason for Recall
Calibrator C not meeting its optical density specification.
Distribution
The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.
Lot / Code Info
Product Number: 507-B (Sigma Diagnostics) Lot Number: 090K6499 Expiration Date: 5-31-2002. Product Number: 2Z921M (Zeus) Lot Number: 00010446 Expiration Date: 06-09-2002
Root Cause
Other
Action Taken
Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.
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