| Class 2 Device Recall Liquid Alkaline Phosphatase (R2) Reagent Set | |
Date Initiated by Firm | June 09, 2006 |
Date Posted | August 10, 2006 |
Recall Status1 |
Terminated 3 on November 19, 2007 |
Recall Number | Z-1390-06 |
Recall Event ID |
35496 |
510(K)Number | K973588 |
Product Classification |
in vitro diagnostic - Product Code CJE
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Product | Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog no. H A416-R2. In vitro diagnostic. |
Code Information |
Lots 500701(exp. 7/06), 508001 (exp. 9/06), 513003 (exp. 11/06), 521601 (exp. 2/07), 530101 (exp. 4/07), 534901 (exp. 6/07), 603301 (exp. 8/07) and 607601 (exp. 9/07). |
Recalling Firm/ Manufacturer |
Pointe Scientific, Inc. 5449 Research Dr Canton MI 48188-2261
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For Additional Information Contact | 800-445-9853 Ext. 110 |
Manufacturer Reason for Recall | The reagent may be contaminated with microorganisms. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via recall letter dated 6/9/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email. |
Quantity in Commerce | 890 L total, all products |
Distribution | Worldwide, including USA, Bolivia, Cameroon, China, Cyprus, Egypt, Greece, India, Israel, Kenya, Korea, Lebanon, Malaysia, Mexico, Nepal, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, Thailand, Trinidad, Turkey, Ukraine United Arab Emirates and Venezuela. |
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 = CJE
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