| Class 2 Device Recall Pointe Scientific | |
Date Initiated by Firm | June 09, 2006 |
Date Posted | September 30, 2006 |
Recall Status1 |
Terminated 3 on November 20, 2007 |
Recall Number | Z-1548-06 |
Recall Event ID |
35499 |
510(K)Number | K972333 |
Product Classification |
Alcohol Assay - Product Code JIX
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Product | Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2. |
Code Information |
Lot 522202, exp. 7/06. |
Recalling Firm/ Manufacturer |
Pointe Scientific, Inc. 5449 Research Dr Canton MI 48188-2261
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For Additional Information Contact | 734-487-8300 |
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 | Other |
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 | 98 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JIX
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