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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Access Immunoassay System CEA

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 Class 2 Device Recall Beckman Coulter Access Immunoassay System CEAsee related information
Date Initiated by FirmApril 12, 2006
Date PostedAugust 01, 2006
Recall Status1 Terminated 3 on April 03, 2012
Recall NumberZ-1313-06
Recall Event ID 35630
510(K)NumberK981985 
Product Classification in vitro diagnostic - Product Code DHX
ProductAccess Immunoassay system CEA, in vitro diagnostic, Part No. 33200
Code Information All codes
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactEri H. Hirumi
714-961-4389
Manufacturer Reason
for Recall		Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.
FDA Determined
Cause 2		Other
ActionA Product Corrective Action letter was sent via US mail the week of April 10, 2006 to all Access CEA customers informing them that the Access CEA Assay could generate decreased values with certain frozen patient specimens. Although they have found it at a low occurrence, it is recommended that specimens should not be frozen prior to analysis until further notice. The letter informs customers that Beckman Coulter has verified sample stability through at least 14 days when properly stored at 2-8 degrees Celsius and shipping stability for 4 days at 2-8 degrees Celsius using cool packs. Firm also advises customers to contact customer technical support or local Beckman Coulter Representative if laboratory is unable to avoid freezing specimens and to review results from frozen CEA samples to ensure that the match the total clinical presentation per the customer''s established laboratory procedure. The letter requests that the notification remain part of the laboratory Quality System documentation and that the response form be returned to the firm within 10 days.
Quantity in Commerce775
DistributionNationwide and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DHX
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