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U.S. Department of Health and Human Services

Class 2 Device Recall Access 2 Immunoassay System

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  Class 2 Device Recall Access 2 Immunoassay System see related information
Date Initiated by Firm May 17, 2016
Create Date October 11, 2018
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-1956-2016
Recall Event ID 74212
510(K)Number K922823  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Code Information Serial No. 505143, 504805, 501368, 504231
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall letter dated 5/17/16 was sent to customers to inform them that Beckman Coulter is recalling the Access 2 Immunoassay System, Remanufactured instrument, because it may not have all the updated thermal components installed. The letter informs customers of the impact and actions to be taken. The letter informs the customers that their Service Representative will contact them to schedule an onsite visit to inspect their instrument and update as needed. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada are instructed to contact their local Beckman Coulter representative.
Quantity in Commerce 4 units total (1 unit in US)
Distribution US, Morocco, Venezuela
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 = JJE and Original Applicant = BIO-RAD LABORATORIES, INC.
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