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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Inc.,

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  Class 2 Device Recall Pointe Scientific Inc., see related information
Date Initiated by Firm June 09, 2006
Date Posted September 30, 2006
Recall Status1 Terminated 3 on November 20, 2007
Recall Number Z-1545-06
Recall Event ID 35499
510(K)Number K882117  
Product Classification Alcohol assay - Product Code JIX
Product Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD.
Code Information Lot 509102; exp. 9/06.
Recalling Firm/
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
Manufacturer Reason
for Recall
Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
FDA Determined
Cause 2
Action Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
Quantity in Commerce 108 units
Distribution Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JIX and Original Applicant = VERICHEM LABORATORIES, INC.