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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Direct Bilirubin Reagent Set

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 Class 2 Device Recall Pointe Scientific Direct Bilirubin Reagent Setsee related information
Date Initiated by FirmJuly 29, 2009
Date PostedMarch 05, 2010
Recall Status1 Terminated 3 on December 06, 2010
Recall NumberZ-1014-2010
Recall Event ID 52851
510(K)NumberK040391 
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
ProductPointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
Code Information Lot 817103-337.
FEI Number 1827821
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
800-445-9853 Ext. 110
Manufacturer Reason
for Recall		R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before beginning running the bilirubin assay.
FDA Determined
Cause 2		Error in labeling
ActionConsignee was notified by letter dated 7/29/2009 and instructed to identify and notify them at once of this product recall. Product is to be returned or destroyed. Customers with questions should contact the firm directly.
Quantity in Commerce2
DistributionCalifornia.
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 = CIG
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