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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Set

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 Class 2 Device Recall Pointe Scientific Liquid Hitachi Calcium Reagent Setsee related information
Date Initiated by FirmNovember 10, 2009
Date PostedMarch 10, 2010
Recall Status1 Terminated 3 on December 10, 2010
Recall NumberZ-1042-2010
Recall Event ID 53784
510(K)NumberK822469 
Product Classification Calcium Reagent Set - Product Code CIC
ProductCalcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
Code Information All lots containing 813401 as part of the lot number.
FEI Number 1827821
Recalling Firm/
Manufacturer		 Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
FDA Determined
Cause 2		Process control
ActionConsignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Quantity in Commerce6 sets and 21 L
DistributionWorldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
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 = CIC
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