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U.S. Department of Health and Human Services

Class 3 Device Recall MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

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  Class 3 Device Recall MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS see related information
Date Initiated by Firm September 27, 2007
Date Posted May 22, 2009
Recall Status1 Terminated 3 on May 27, 2009
Recall Number Z-1396-2009
Recall Event ID 48692
510(K)Number K021229  
Product Classification Myoglobin, antigen, antiserum, control - Product Code DDR
Product Access Myoglobin Reagents Kits, Part Number: 973243.

The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Code Information All Lot Numbers.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact
714-993-5321 Ext. 8383
Manufacturer Reason
for Recall		 Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes
FDA Determined
Cause 2		 Labeling False and Misleading
Action An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and (3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.
Quantity in Commerce 20,727
Distribution Nationwide and 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 = DDR and Original Applicant = BECKMAN COULTER, INC.
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