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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems, Discrete photometric chemistry analyzer

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  Class 2 Device Recall Access Immunoassay Systems, Discrete photometric chemistry analyzer see related information
Date Initiated by Firm November 08, 2004
Date Posted November 30, 2004
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-0265-05
Recall Event ID 30421
510(K)Number K922823  
Product Classification Acid, Folic, Radioimmunoassay - Product Code CGN
Product Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
Code Information Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401. 
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen M. Jacker
714-961-3666
Manufacturer Reason
for Recall		 A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.
FDA Determined
Cause 2		 Other
Action Product Corrective Action (PCA) letter that informs customers (who ordered Access Chlamydia reagent in the past 24 months and have an Access 2 Immunoassay System) of this potential issue sent via US mail on November 8, 2004. The letter instructs customers to use unique Sample IDs for all samples assayed on the system - including those which have been manipulated offline prior to assay. A Technical Information Update will be issued to inform all support personnel of this issue.
Quantity in Commerce 1,197
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 = CGN and Original Applicant = BIO-RAD LABORATORIES, INC.
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