AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. 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-0172-2009
- Quantity
- 25 vials
- 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
Lot 728504-079; 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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