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U.S. Department of Health and Human Services

Class 3 Device Recall Access AFP QC

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  Class 3 Device Recall Access AFP QC see related information
Date Initiated by Firm April 21, 2010
Date Posted August 11, 2010
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-2208-2010
Recall Event ID 55678
510(K)Number K981864  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product Access Immunoassay Systems AFP QC, Part Number: 33219

The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems.
Code Information Lot Numbers: 911158, 911581, and 917631
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K O' Donovan PHD
714-961-4483
Manufacturer Reason
for Recall		 The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established refere
FDA Determined
Cause 2		 Other
Action A Product Corrective Action (PCA) letter was sent on the week of April 19, 2010 to all customers who purchased the Access Immunoassay Systems AFP QC material, lot numbers referenced above. The letter provided the customers with an explanation of the problem identified and instructed the customers to (1) Please discard all remaining inventory of the three Access AFP QC kit lots identified above, including all vials of QC1, QC2, and QC3. (2) Please review your ac and patient results obtained while using the affected control lots. Interpret Access AFP test results in light of the clinical presentation of the patient, including: symptoms, clinical history, data from other tests and other appropriate information. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. (4) Complete and return the enclosed response form within 10 days so we can be assured that you have received this important notification. For customers that need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.
Quantity in Commerce 166
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 = JJX and Original Applicant = BECKMAN COULTER, INC.
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