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U.S. Department of Health and Human Services

Class 2 Device Recall Ranbaxy

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  Class 2 Device Recall Ranbaxy 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-1544-06
Recall Event ID 35499
Product Classification Alcohol - ethyl alcohol assay - Product Code JIX
Product Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marketed in India by Ranbaxy Laboratories Ltd., New Delhi; Catalog # A7504-150-S.
Code Information Lot 507401.
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 5 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.