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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Synchron Ammonia (AMM) Reagent

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  Class 2 Device Recall Beckman Coulter Synchron Ammonia (AMM) Reagent see related information
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
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
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.
510(K) Database 510(K)s with Product Code = JIF and Original Applicant = BECKMAN COULTER, INC.
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