Date Initiated by Firm | March 26, 2009 |
Date Posted | April 16, 2012 |
Recall Status1 |
Terminated 3 on April 18, 2012 |
Recall Number | Z-1432-2012 |
Recall Event ID |
53049 |
510(K)Number | K984402 |
Product Classification |
Enzymatic method, ammonia - Product Code JIF
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Product | SYNCHRON Ammonia (AMM) Reagent
Product Usage:
AMM reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators, is intended for the quantitative determination of Ammonia concentration in human plasma. |
Code Information |
Lot Number M808278 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 200 S Kraemer Blvd Brea CA 92821-6208
|
For Additional Information Contact | 714-993-5321 |
Manufacturer Reason for Recall | The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems. |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | Beckman Coulter mailed a Product Corrective Action (PCA) Letter on April 13, 2009 dated April 10, 2009 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue use and discard appropriately the lot number(s) of the affected product and contact their Customer Service Representative at (800) 526-3821 (US), or (800)463-7828 for reagent replacement. Customers were instructed to complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain records.
Customers were told to call the Customer Support Center (Hotline) at (800) 854-3633 with any questions regarding the PCA letter. |
Quantity in Commerce | 3,388 kits |
Distribution | Worldwide Distribution - USA (nationwide) and the country of Canada |
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 = JIF
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