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U.S. Department of Health and Human Services

Class 2 Device Recall AST R1

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 Class 2 Device Recall AST R1see related information
Date Initiated by FirmAugust 25, 2008
Date PostedOctober 22, 2008
Recall Status1 Terminated 3 on November 27, 2009
Recall NumberZ-0172-2009
Recall Event ID 49131
510(K)NumberK941132 
Product Classification Reagent - Product Code CIT
ProductAST 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
Code Information Lot 728504-079; Exp. 4/09.
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
FDA Determined
Cause 2		Material/Component Contamination
ActionConsignees 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.
Quantity in Commerce25 vials
DistributionNationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CIT
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