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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-1043-2010
Recall Event ID 53784
510(K)NumberK822469 
Product Classification Calcium Reagent Set - Product Code CIC
ProductCalcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. 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.
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 Commerce4 sets and 9 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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