Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in human serum
This recall has been terminated (originally issued October 22, 2008).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- August 25, 2008
- Posted
- October 22, 2008
- Terminated
- November 27, 2009
- Recall Number
- Z-0171-2009
- Quantity
- 109 kits
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
Distribution
Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.
Lot / Code Info
A7561-150 lots 728504-046 and 728504-094. A7561-450 lot 728504-063. Exp. 4/09.
Root Cause
Material/Component Contamination
Action Taken
Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.
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