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Class 2 Device Recall Pointe Scientific Liquid Glucose HEX |
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Date Initiated by Firm |
June 07, 2006 |
Date Posted |
August 03, 2006 |
Recall Status1 |
Terminated 3 on November 19, 2007 |
Recall Number |
Z-1327-06 |
Recall Event ID |
35498 |
510(K)Number |
K002199
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Product Classification |
in vitro diagnostic - Product Code CFR
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Product |
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R2. |
Code Information |
Lots 511901, exp. 4/07 and 525101, exp. 9/07. |
Recalling Firm/ Manufacturer |
Pointe Scientific, Inc. 5449 Research Dr Canton MI 48188-2261
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For Additional Information Contact |
734-487-8300
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Manufacturer Reason for Recall |
Product does not meet performance specifications through its labeled expiration period.
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FDA Determined Cause 2 |
Other |
Action |
Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks. |
Quantity in Commerce |
13 kits |
Distribution |
Worldwide, including USA, Canada, China, Panama, Russia and Trinidad. |
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 = CFR and Original Applicant = POINTE SCIENTIFIC, INC.
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