Date Initiated by Firm | June 07, 2006 |
Date Posted | August 03, 2006 |
Recall Status1 |
Terminated 3 on November 19, 2007 |
Recall Number | Z-1326-06 |
Recall Event ID |
35498 |
510(K)Number | K002199 |
Product Classification |
in vitro diagnostic - Product Code CFR
|
Product | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog number HG420-R1. |
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
|
For Additional Information Contact | 734-487-8300 |
Manufacturer Reason for Recall | Product does not meet performance specifications through its labeled expiration period. |
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 | 14 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
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